SPY-PHI HANDHELD IMAGER
Report
- Report Number
- 3012345110-2019-00011
- Event Type
- Death
- Date Received
- December 9, 2019
- Date of Event
- November 7, 2019
- Report Date
- June 19, 2020
- Manufacturer
- NOVADAQ TECHNOLOGIES
- Product Code
- OWN
- PMA / PMN Number
- K162885
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
ALLEGED FAILURE: "21 YEAR OLD FEMALE PATIENT HAD ¿VERY LARGE, BENIGN RETROPERITONEAL TUMOR¿. INITIAL SURGERY WAS PERFORMED ON THURSDAY 11/7 IN THE LATE AFTERNOON/EARLY EVENING, REP WAS NOT PRESENT OR NOTIFIED. ABRAZO CENTRAL¿S SPY PHI IS ON A ROLLING CART HOOKED TO AUXILIARY MONITOR, NO SDC FOR RECORDING. INTESTINES, PANCREAS, ETC WERE MOVED ¿OUT OF THE WAY¿ OR OUT OF THE BODY TO EXCISE THIS VERY LARGE TUMOR. PER THE SURGEON, THE BOWEL LOOKED DUSKY WHILE OUTSIDE THE CAVITY BUT ONCE PLACED BACK, BEGAN TO PINK UP. THE SPY PHI WAS UTILIZED TO CONFIRM PERFUSION. ACCORDING TO ANESTHESIA AND THE SURGEON, THE CORRECT DOSING WAS GIVEN FOLLOWED BY A FLUSH, LIGHTS WERE TURNED OUT AND EVERYTHING LOOKED ¿GREEN AND PERFUSED¿. DR. CHAMBERLAIN CLOSED. NO COLON RESECTION OCCURRED. FRIDAY THE PATIENTS LABS BEGAN TO DETERIORATE. CAT SCAN WAS DONE AND SEEMED TO CONFIRM PERFUSION TO THE AREA BUT PATIENT CONTINUED TO DO POORLY. PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6). UPON OPENING, THE STOMACH AND BOWELS WERE DARK AND DEAD TO THE NAKED EYE. THE SURGEONS SPIED AGAIN¿ EVERYTHING FLUORESCED VERY BRIGHT GREEN. THEY CONTINUED OPERATING AND SPIED AGAIN 15 MINUTES LATER, EVERYTHING WAS STILL VERY GREEN BUT THE STOMACH AND BOWELS WERE VISIBLY DEAD AND THE PATIENT WAS UNWELL. PICTURES WERE TAKEN ON A VERY OLD IPHONE OF THE FINAL SPY IMAGES (PROVIDED). THEY CLOSED THE PATIENT UP AND SHE PASSED AWAY A FEW DAYS LATER. BOTH SURGEONS AND ALL STAFF AT THIS ACCOUNT ARE VERY CONCERNED AND ARE NOW SKEPTICAL OF THE SPY MACHINE. THE SURGEONS WANT AN EXPLANATION FOR THE SPY RESULT. BOTH SURGEONS HAVE STATED THERE WAS NO WAY THE BOWEL WAS GETTING ANY ARTERIAL FLOW. A COMPLAINT AND REQUEST FOR AN EVALUATION FOR THE UNIT WAS PLACED MONDAY, NOVEMBER 11TH BY THE REP. THE SPY PHI SEEMS TO BE OPERATING NORMALLY, PER AN ICG TEST DONE AT THE ACCOUNT. SURGEONS WANT TO CONTINUE USING THE SPY BUT ARE VERY UPSET BY WHAT HAPPENED AND WOULD LIKE CLINICAL RESOLUTION." PROBABLE ROOT CAUSE/S: ROOT CAUSE OF ALLEGED REPORTED ISSUE COULD NOT BE DETERMINED. A NUMBER OF MECHANICAL AND SOFTWARE ISSUES WERE IDENTIFIED FROM DEVICE LOGS AND INITIAL ANALYSIS OF PROVIDED PHOTOGRAPHIC EVIDENCE ALSO DEVELOPED SEVERAL POTENTIAL SCENARIOS INVOLVING VPI MALFUNCTION, MANUFACTURING ERRORS AND USER TAMPERING. HOWEVER, INVESTIGATION RULES OUT ANY POTENTIAL DEVICE-RELATED ISSUES AS A CAUSE OF REPORTED ISSUE. DURING ANALYSIS OF THE DEVICE LOGS, USAGE PATTERNS IDENTIFIED IN THE RELEVANT SESSIONS INDICATE THAT THE SPY PHI IMAGING SYSTEM WAS POTENTIALLY NOT BEING PROPERLY UTILIZED FOR ASSESSING PERFUSION IN THE SPECIFIC ANATOMY ASSOCIATED WITH THE SURGICAL PROCEDURE. HOWEVER, THE INFORMATION PIECED TOGETHER FROM THE LOGS ONLY PROVIDE A LIMITED VIEW OF HOW THE SPY PHI IMAGER WAS UTILIZED DURING EACH SPECIFIC SURGICAL CASE AND FURTHER DISCUSSION WITH THE ATTENDING SURGEON WILL BE REQUIRED TO CONFIRM THE SEQUENCE OF EVENTS LEADING TO THE FINAL MEDICAL DECISIONS MADE DURING EACH CASE. DEVICE WILL BE RETESTED IN ACCORDANCE WITH IN-PROCESS TEST PROCEDURES TO ENSURE THAT UNIT MEETS MANUFACTURER SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
ALLEGED FAILURE:21 YEAR OLD FEMALE PATIENT HAD ¿VERY LARGE, BENIGN RETROPERITONEAL TUMOR¿. INITIAL SURGERY WAS PERFORMED ON THURSDAY 11/7 IN THE LATE AFTERNOON/EARLY EVENING, REP WAS NOT PRESENT OR NOTIFIED. ABRAZO CENTRAL¿S SPY PHI IS ON A ROLLING CART HOOKED TO AUXILIARY MONITOR, NO SDC FOR RECORDING. INTESTINES, PANCREAS, ETC WERE MOVED ¿OUT OF THE WAY¿ OR OUT OF THE BODY TO EXCISE THIS VERY LARGE TUMOR. PER THE SURGEON, THE BOWEL LOOKED DUSKY WHILE OUTSIDE THE CAVITY BUT ONCE PLACED BACK, BEGAN TO PINK UP. THE SPY PHI WAS UTILIZED TO CONFIRM PERFUSION. ACCORDING TO ANESTHESIA AND THE SURGEON, THE CORRECT DOSING WAS GIVEN FOLLOWED BY A FLUSH, LIGHTS WERE TURNED OUT AND EVERYTHING LOOKED ¿GREEN AND PERFUSED¿. DR. (B)(6) CLOSED. NO COLON RESECTION OCCURRED. ON (B)(6) THE PATIENTS LABS BEGAN TO DETERIORATE. CAT SCAN WAS DONE AND SEEMED TO CONFIRM PERFUSION TO THE AREA BUT PATIENT CONTINUED TO DO POORLY. PATIENT WAS BROUGHT BACK TO THE OR ON SATURDAY, NOVEMBER 9TH. UPON OPENING, THE STOMACH AND BOWELS WERE DARK AND DEAD TO THE NAKED EYE. THE SURGEONS SPIED AGAIN. EVERYTHING FLUORESCED VERY BRIGHT GREEN. THEY CONTINUED OPERATING AND SPIED AGAIN 15 MINUTES LATER, EVERYTHING WAS STILL VERY GREEN BUT THE STOMACH AND BOWELS WERE VISIBLY DEAD AND THE PATIENT WAS UNWELL. PICTURES WERE TAKEN ON A VERY OLD IPHONE OF THE FINAL SPY IMAGES (PROVIDED). THEY CLOSED THE PATIENT UP AND SHE PASSED AWAY A FEW DAYS LATER. BOTH SURGEONS AND ALL STAFF AT THIS ACCOUNT ARE VERY CONCERNED AND ARE NOW SKEPTICAL OF THE SPY MACHINE. THE SURGEONS WANT AN EXPLANATION FOR THE SPY RESULT. BOTH SURGEONS HAVE STATED THERE WAS NO WAY THE BOWEL WAS GETTING ANY ARTERIAL FLOW. A COMPLAINT AND REQUEST FOR AN EVALUATION FOR THE UNIT WAS PLACED MONDAY, NOVEMBER 11TH BY THE REP. THE SPY PHI SEEMS TO BE OPERATING NORMALLY, PER AN ICG TEST DONE AT THE ACCOUNT. SURGEONS WANT TO CONTINUE USING THE SPY BUT ARE VERY UPSET BY WHAT HAPPENED AND WOULD LIKE CLINICAL RESOLUTION." PROBABLE ROOT CAUSE/S: ROOT CAUSE OF ALLEGED REPORTED ISSUE COULD NOT BE DETERMINED. A NUMBER OF MECHANICAL AND SOFTWARE ISSUES WERE IDENTIFIED FROM DEVICE LOGS AND INITIAL ANALYSIS OF PROVIDED PHOTOGRAPHIC EVIDENCE ALSO DEVELOPED SEVERAL POTENTIAL SCENARIOS INVOLVING VPI MALFUNCTION, MANUFACTURING ERRORS AND USER TAMPERING. HOWEVER, INVESTIGATION RULES OUT ANY POTENTIAL DEVICE-RELATED ISSUES AS A CAUSE OF REPORTED ISSUE. DURING ANALYSIS OF THE DEVICE LOGS, USAGE PATTERNS IDENTIFIED IN THE RELEVANT SESSIONS INDICATE THAT THE SPY PHI IMAGING SYSTEM WAS POTENTIALLY NOT BEING PROPERLY UTILIZED FOR ASSESSING PERFUSION IN THE SPECIFIC ANATOMY ASSOCIATED WITH THE SURGICAL PROCEDURE. HOWEVER, THE INFORMATION PIECED TOGETHER FROM THE LOGS ONLY PROVIDE A LIMITED VIEW OF HOW THE SPY PHI IMAGER WAS UTILIZED DURING EACH SPECIFIC SURGICAL CASE AND FURTHER DISCUSSION WITH THE ATTENDING SURGEON WILL BE REQUIRED TO CONFIRM THE SEQUENCE OF EVENTS LEADING TO THE FINAL MEDICAL DECISIONS MADE DURING EACH CASE. DEVICE WILL BE RETESTED IN ACCORDANCE WITH IN-PROCESS TEST PROCEDURES TO ENSURE THAT UNIT MEETS MANUFACTURER SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. STRYKER ENDOSCOPY. 5900 OPTICAL CT. SAN JOSE, CA 95138. JUNE 12, 2020. MS. (B)(4). FOOD AND DRUG ADMINISTRATION. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICE REPORTING. 8400 CORPORATE DRIVE, SUITE 500. LANDOVER, MD 20785. TO MS. (B)(4), THIS LETTER IS A FOLLOW UP TO YOUR REQUEST FOR ADDITIONAL INFORMATION DATED 18-MAR-2020 RELATED TO CASE 3012345110-2019-00011, STRYKER REFERENCE (B)(4). PLEASE LET ME KNOW IF YOU HAVE ADDITIONAL QUESTIONS. YOURS SINCERELY, (B)(4). ASSOCIATE REGULATORY COMPLIANCE MANAGER, STRYKER ENDOSCOPY, T: (B)(4), EMAIL: (B)(4)@STRYKER.COM. CC: (B)(4). SR. DIRECTOR, REGULATORY AFFAIRS AND CLINICAL SCIENCES, STRYKER ENDOSCOPY, 5900 OPTICAL COURT, SAN JOSE, CA 95138. EMAIL: (B)(4) AT STRYKER.COM. PRODUCT DESCRIPTION: SPY-PHI HANDHELD HH9030. CATALOG #: HH9030. EVENT DESCRIPTION: ¿21 YEAR OLD FEMALE PATIENT HAD ¿VERY LARGE, BENIGN RETROPERITONEAL TUMOR¿. INITIAL SURGERY WAS PERFORMED ON (B)(6) IN THE LATE AFTERNOON/EARLY EVENING, REP WAS NOT PRESENT OR NOTIFIED. ABRAZO CENTRAL¿S SPY PHI IS ON A ROLLING CART HOOKED TO AUXILIARY MONITOR, NO SDC FOR RECORDING. INTESTINES, PANCREAS, ETC WERE MOVED ¿OUT OF THE WAY¿ OR OUT OF THE BODY TO EXCISE THIS VERY LARGE TUMOR. PER THE SURGEON, THE BOWEL LOOKED DUSKY WHILE OUTSIDE THE CAVITY BUT ONCE PLACED BACK, BEGAN TO PINK UP. THE SPY PHI WAS UTILIZED TO CONFIRM PERFUSION. ACCORDING TO ANESTHESIA AND THE SURGEON, THE CORRECT DOSING WAS GIVEN FOLLOWED BY A FLUSH, LIGHTS WERE TURNED OUT AND EVERYTHING LOOKED ¿GREEN AND PERFUSED¿. DR. (B)(6) CLOSED. NO COLON RESECTION OCCURRED. FRIDAY THE PATIENTS LABS BEGAN TO DETERIORATE. CAT SCAN WAS DONE AND SEEMED TO CONFIRM PERFUSION TO THE AREA BUT PATIENT CONTINUED TO DO POORLY. PATIENT WAS BROUGHT BACK TO THE OR ON SATURDAY, NOVEMBER 9TH. UPON OPENING, THE STOMACH AND BOWELS WERE DARK AND DEAD TO THE NAKED EYE. THE SURGEONS SPIED AGAIN¿ EVERYTHING FLUORESCED VERY BRIGHT GREEN. THEY CONTINUED OPERATING AND SPIED AGAIN 15 MINUTES LATER, EVERYTHING WAS STILL VERY GREEN BUT THE STOMACH AND BOWELS WERE VISIBLY DEAD AND THE PATIENT WAS UNWELL. PICTURES WERE TAKEN ON A VERY OLD IPHONE OF THE FINAL SPY IMAGES (PROVIDED). THEY CLOSED THE PATIENT UP AND SHE PASSED AWAY A FEW DAYS LATER. BOTH SURGEONS AND ALL STAFF AT THIS ACCOUNT ARE VERY CONCERNED AND ARE NOW SKEPTICAL OF THE SPY MACHINE. THE SURGEONS WANT AN EXPLANATION FOR THE SPY RESULT. BOTH SURGEONS HAVE STATED THERE WAS NO WAY THE BOWEL WAS GETTING ANY ARTERIAL FLOW. A COMPLAINT AND REQUEST FOR AN EVALUATION FOR THE UNIT WAS PLACED MONDAY, NOVEMBER 11TH BY THE REP. THE SPY PHI SEEMS TO BE OPERATING NORMALLY, PER AN ICG TEST DONE AT THE ACCOUNT. SURGEONS WANT TO CONTINUE USING THE SPY BUT ARE VERY UPSET BY WHAT HAPPENED AND WOULD LIKE CLINICAL RESOLUTION.¿ FOR REVIEWER¿S CONVENIENCE, YOUR ORIGINAL QUESTIONS ARE IN BOLD FONT AND OUR RESPONSES ARE IN REGULAR FONT BELOW. PLEASE PROVIDE THE DISPOSITION OF THE DEVICE, INCLUDING INFORMATION ON YOUR EFFORTS TO ACQUIRE OR HAVE THE DEVICE RETURNED FOR INVESTIGATION. FOR REUSABLE DEVICES, INDICATE WHETHER THE DEVICE IS STILL IN USE. THE DEVICE WAS RETURNED FOR INVESTIGATION. FOLLOWING INVESTIGATION, DEVICE WAS REFURBISHED AND RETESTED TO ENSURE THAT IT STILL MEETS MANUFACTURER SPECIFICATIONS BEFORE BEING RETURNED TO CUSTOMER. IF THE DEVICE DID NOT FUNCTION OR PERFORM AS EXPECTED, PLEASE DESCRIBE WHICH DEVICE FUNCTION OR FEATURE DID NOT PERFORM AS INTENDED, AND THE MANNER IN WHICH THE DEVICE DID NOT FUNCTION AS EXPECTED. ADDITIONALLY, PLEASE DISCUSS WHETHER THE UNEXPECTED FUNCTION OR BEHAVIOR RESULTED IN THE EVENT DESCRIBED. THE DEVICE WAS REPORTED AS HAVING A MISLEADING FLUORESCENCE DISPLAY. HOWEVER, INVESTIGATION OF THE DEVICE AND REVIEW OF THE DEVICE LOGS CONCLUDED THE DEVICE HAD PERFORMED AS INTENDED. USING THE SPY-PHI SYSTEM, INFORMATION REGARDING PERFUSION SHOULD BE BASED ON EVALUATION OF INGRESS AND EGRESS (I.E. DYNAMIC INCREASE AND DECREASE OF FLUORESCENCE AFTER ICG INJECTION). IN THIS CASE, "GOOD PERFUSION" WAS LIKELY BASED ON THE PRESENCE OF FLUORESCENCE AS OPPOSED TO OBSERVED INGRESS AND EGRESS. PLEASE PROVIDE THE TOTAL NUMBER OF DEVICES MANUFACTURED, DISTRIBUTED AND, IF AVAILABLE, USED PER YEAR OVER THE LAST THREE YEARS FOR THE MEDICAL DEVICE IDENTIFIED IN THE MEDICAL DEVICE REPORT. PLEASE INDICATE THE PROPORTIONS DISTRIBUTED IN THE US AND OUTSIDE THE US. (PLEASE SEE EMAILED VERSION - TABLE CANNOT TRANSFER). PLEASE PROVIDE A COPY (OR ELECTRONIC LOCATION) OF ALL CURRENT LABELING FOR THE DEVICE, INCLUDING DIRECTIONS FOR USE, CAUTION STATEMENTS, TECHNICAL MANUALS, AND PRODUCT PERFORMANCE REPORTS. THERE ARE TWO LABELS ON THE HH9030 DEVICE, 4-0003109 AND 026-80101-001. THE INSTRUCTIONS FOR USE ARE CAPTURED IN DOCUMENT 4-0003039. PLEASE FIND THE PDF FILES ATTACHED TO THE REPORT. PLEASE PROVIDE A MORE COMPLETE DESCRIPTION OF THIS EVENT INCLUDING ANY RELEVANT DETAILS SURROUNDING THE EVENT. PLEASE REFER TO THE EVENT DESCRIPTION AS REPORTED ABOVE. IT IS UNCLEAR IF THIS EVENT WAS A RESULT OF OFF-LABEL USE OF THIS DEVICE. PLEASE PROVIDE ADDITIONAL INFORMATION TO EXPLAIN WHETHER YOU BELIEVE THIS EVENT REPRESENTED AN OFF-LABEL USE OF THE DEVICE. THE SPY-PHI SYSTEM IN THIS EVENT WAS BEING USED TO IMAGE PERFUSION IN THE BOWEL. THE SPY-PHI SYSTEM IS INDICATED FOR FLUORESCENCE IMAGING OF BLOOD FLOW AND TISSUE PERFUSION BEFORE, DURING AND AFTER GASTROINTESTINAL SURGICAL PROCEDURES. PLEASE PROVIDE THE PRIMARY AND SECONDARY CAUSE OF DEATH AS IT WAS REPORTED BY THE PATIENT'S PHYSICIAN, AS IT APPEARS IN THE MEDICAL RECORD OR AS IT IS DESCRIBED IN THE AUTOPSY REPORT. PLEASE INCLUDE THE INFORMATION SOURCE USED IN YOUR RESPONSE. MEDICAL RECORDS AND AUTOPSY REPORTS WERE NOT PROVIDED TO OUR FIRM BY THE PATIENT'S PHYSICIAN. PLEASE PROVIDE THE RESULTS FOR ANY INVESTIGATION, EVALUATION, AND/OR FAILURE ANALYSIS, INCLUDING UNDERLYING CAUSE IDENTIFICATION, RELEVANT TO THE REPORTED EVENT. PLEASE INCLUDE: A. AN EXPLANATION FOR THE REASON FOR THIS OCCURRENCE BASED ON YOUR FOLLOW-UP WITH THE REPORTING FACILITY OR INDIVIDUAL. INVESTIGATIONS SUGGEST THAT THE SPY-PHI IMAGING SYSTEM WAS POTENTIALLY NOT BEING PROPERLY UTILIZED FOR ASSESSING PERFUSION IN THE SPECIFIC ANATOMY ASSOCIATED WITH THE SURGICAL PROCEDURE. HOWEVER, THIS COULD NOT BE CONFIRMED WITHOUT FURTHER INFORMATION FROM THE ATTENDING SURGEON. A COMPLETE DESCRIPTION OF INVESTIGATION AND ANALYSIS METHODOLOGY(IES) USED, PHOTOGRAPHIC EVIDENCE PROVIDED BY THE REPORTING PARTIES WERE REVIEWED TO IDENTIFY POTENTIAL DEVICE FAILURES WHICH COULD LEAD TO THE REPORTED ISSUE. DEVICE LOGS WERE ALSO REVIEWED FOR DEVICE FAILURES, FLUORESCENCE LEVEL READINGS OR DEVICE TAMPERING. MANUFACTURING RECORDS WERE ALSO REVIEWED TO IDENTIFY POTENTIAL MANUFACTURING NON-CONFORMANCES. DEVICE WAS INSPECTED FOR EVIDENCE OF DEVICE TAMPERING OR ABUSE. AN IDENTIFICATION OF THE SPECIFIC FAILURE MODE{S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED, AND NO DEVICE FAILURES WERE IDENTIFIED. ANY CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. INVESTIGATIONS DID NOT FIND EVIDENCE SUGGESTING THE DEVICE WAS NOT PERFORMING AS INTENDED. INVESTIGATIONS SUGGEST THAT THE SPY-PHI IMAGING SYSTEM WAS POTENTIALLY NOT BEING PROPERLY UTILIZED BY USER FOR ASSESSING PERFUSION IN THE SPECIFIC ANATOMY ASSOCIATED WITH THE SURGICAL PROCEDURE. HOWEVER, THIS COULD NOT BE CONFIRMED WITHOUT FURTHER INFORMATION FROM THE ATTENDING SURGEON. CLINICAL INVESTIGATION BY STRYKER CONFIRMED AN OCCULTED SUPERIOR MESENTERIC ARTERY WHICH CAUSED MESENTERIC ISCHEMIA WHICH ULTIMATELY LED TO PATIENT OUTCOME. PLEASE PROVIDE ANY EVALUATION OF OTHER INFORMATION USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. BEYOND THE INVESTIGATION RESULTS OF THE REPORTED DEVICE, NO FURTHER INFORMATION COULD BE ATTAINED FOR EVALUATION. PLEASE PROVIDE A COMPLETE LIST OF MEDICAL DEVICE REPORTS (MDRS) THAT YOU HAVE DETERMINED ARE RELATED TO THIS SAME PROBLEM/ISSUE. PLEASE IDENTIFY HOW MANY COMPLAINTS (I.E. FROM ALL SOURCES, INCLUDING BUT NOT LIMITED TO FIELD SERVICE RECORDS, REPAIR HISTORY RECORDS, ETC.) THAT YOUR FIRM HAS RECEIVED IN THE PAST 2 YEARS THAT ARE RELATED TO THIS SAME REPORTED DEVICE PROBLEM. THERE HAVE BEEN 0 SIMILAR INCIDENCES RELATED TO THIS SAME REPORTED DEVICE PROBLEM IN THE PAST 2 YEARS. WHAT ACTIONS HAS YOUR FIRM TAKEN TO ADDRESS THIS PROBLEM? THE REPORTED ALLEGED FAILURE MODE WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCES. POTENTIAL RISKS RELATING TO MISUSE SIMILAR TO THE EVENT REPORTED ARE ALSO BEING REEVALUATED THROUGH A NONCONFORMANCE.
IT WAS REPORTED THAT A TUMOR REMOVAL PROCEDURE RESULTED IN PATIENT DEATH. PLEASE NOTE, AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.
IT WAS REPORTED THAT A TUMOR REMOVAL PROCEDURE RESULTED IN PATIENT DEATH. PLEASE NOTE, AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
IT WAS REPORTED THAT A TUMOR REMOVAL PROCEDURE RESULTED IN PATIENT DEATH. PLEASE NOTE, AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1234585 | SPY-PHI HANDHELD IMAGER | CONFOCAL OPTICAL IMAGING | OWN | NOVADAQ TECHNOLOGIES | HH18280587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Death |