ENDOWRIST

Report

Report Number: 2955842-2020-11448
Event Type: Death
Date Received: January 5, 2021
Date of Event: December 10, 2020
Report Date: December 11, 2020
Manufacturer: INTUITIVE SURGICAL, INC
Product Code: NAY
UDI-DI: 00886874112427
PMA / PMN Number: K140553
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY REVIEW WAS CONDUCTED AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM ERROR LOG REVIEW WAS CONDUCTED. WHILE THERE WAS RECORD OF TRUMPF TABLE, TOUCHSCREEN, AUDIO AND SET UP JOINT (SUJ) MESSAGES, THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE INSTRUMENT LOGS WAS PERFORMED. WITH EXCEPTION OF A LARGE NEEDLE DRIVER INSTRUMENT PN: 470006-12, // LN: N10190725-0141 WITH 6 OF 10 USES REMAINING AND THE STAPLER 45 PN: 470298-12 // LN: T10181211-0076 WITH 23 OF 50 USES REMAINING, ALL OTHER REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES. A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. AN ISI ADVANCED FAILURE ANALYST (AFA) ENGINEER CONDUCTED A STAPLER LOG REVIEW AND FINDINGS WERE AS FOLLOWS: LOGS SHOW THAT STAPLER INSTRUMENT PN 470298-12, LOT T10181211-0076 FIRED SIX RELOADS (FIVE WHITE FOLLOWED BY ONE BLUE). ALL FIRINGS WERE COMPLETED. THE FIRST FIVE FIRINGS (ALL USING WHITE RELOADS) WERE COMPLETED WITHOUT HAVING ANY INCOMPLETE CLAMPS. THE NEXT INSTALL WAS WITH A WHITE RELOAD AND THERE WERE TEN INCOMPLETE CLAMPS IN ELEVEN ATTEMPTS (THE COMPLETED CLAMP WAS THE SECOND ATTEMPTED CLAMP) AND THE USER NEVER ATTEMPTED TO FIRE WITH THIS WHITE RELOAD. THE INSTRUMENT WAS REMOVED AND A BLUE RELOAD WAS USED ON THE NEXT INSTALL. THIS INSTALL WITH A BLUE RELOAD HAD FIVE INCOMPLETE CLAMPS IN SEVEN ATTEMPTS (CLAMPS COMPLETED ON ATTEMPTS # 4 AND # 7) AND WITH A COMPLETED FIRING. AN ISI MEDICAL SAFETY OFFICER CONDUCTED AN EVENT REVIEW AND FINDINGS WERE AS FOLLOWS: THE DESCRIBED EVENT IS NOT UNIQUE TO AN INTUITIVE PRODUCT OR PROCEDURE AND THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER OR NOT AN INTUITIVE PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT. BASED UPON THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENT, IT IS UNCLEAR IF THE PATIENTS BOWEL LEAK AND SUBSEQUENT DEATH WAS CAUSED BY THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES OR BY THE PATIENTS UNDERLYING CONDITIONS OF MALNOURISHMENT, CORONARY ARTERY DISEASE, CANCER HISTORY, AND HYPERTENSION. IN AN ARTICLE FROM HAO XU, ENTITLED MALNUTRITION-RELATED FACTORS INCREASED THE RISK OF ANASTOMOTIC LEAK FOR RECTAL CANCER PATIENTS UNDERGOING SURGERY, MAY 2020, BIOMED RESEARCH INTERNATIONAL, VOLUME 2020, ARTICLE ID 50596790, IT WAS FOUND THAT ANASTOMOTIC LEAK WAS A COMMON POSTOPERATIVE COMPLICATION IN RECTAL CANCER OPERATIONS. THE ARTICLE ALSO FOUND THAT PATIENTS WITH DIABETES AND LOW PERIOPERATIVE ALBUMIN (MALNUTRITION) ARE AT INCREASED RISK OF DEVELOPING AN ANASTOMOTIC LEAK. IT WAS NOT CLEAR WHAT WAS MEANT BY THE SURGEON STATEMENT THE STAPLES HAD OPENED-UP, THE STAPLES ARE NOT GOING TO UNDERGO ANY ADDITIONAL CONFIGURATION CHANGE ONCE THEY HAVE BEEN DEPLOYED. THE LIKELY SCENARIO, IS THAT THE TISSUE WAS NOT ABLE TO HOLD THE STAPLES AS THE PATIENTS UNDERLYING MEDICAL CONDITIONS IN COMBINATION WITH THE USE OF THE WHITE LOAD. THE COMBINATION OF THE TWO LIMITED THE PERFUSION OF OXYGEN AND NUTRIENTS TO HEAL THE TISSUE RESULTING IN ISCHEMIC TISSUE. THE NON-VIABLE TISSUE CAUSED THE STAPLES TO ESSENTIALLY PULL THROUGH THE ISCHEMIC TISSUE. THE EVENT TIME-LINE IS SUGGESTIVE OF AN ISCHEMIA, WHICH IS SUPPORTS THE LIKELIHOOD OF THE ABOVE SCENARIO. THERE IS AN ADDITIONAL ELEMENT OF DELAY OF CARE FROM THE TIME WHEN THE PATIENT CALLED THE OFFICE COMPLAINING OF PAIN UNTIL THE PATIENT RETURNED TO THE OPERATING ROOM. THE POST-OPERATIVE COURSE WAS NOT TYPICAL. THERE WAS NO REPORT OF THE PATIENT BEING EVALUATED AT THE FIRST CALL FOR ADDITIONAL PAIN MEDICATIONS. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED ONE CENTIMETER UNSPECIFIED STAPLE LINE LEAK. AS A RESULT, THE PATIENT UNDERWENT A SECOND SURGERY TO REPAIR THE LEAK AND THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2020. THE SURGEON ATTRIBUTED THE CAUSE OF THE ISSUE TO THE SURGEONS INCORRECT SELECTION IN TYPE OF RELOAD. WHILE THE SURGEON CONFIRMED A COMPLETE STAPLE LINE DURING THE INITIAL PROCEDURE, THE SURGEON STATED THAT SHE SHOULDNT HAVE USED A VASCULAR LOAD. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2020, THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2020 FOR A POST-OPERATIVE VISIT AND A 1CM STAPLE LINE LEAK WAS DISCOVERED. A SECOND SURGERY WAS PERFORMED ON (B)(6) 2020 TO FIX THE LEAK. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CLINICAL SALES REPRESENTATIVE (CSR) WHO HAD SPOKEN WITH THE SURGEON ABOUT THE REPORTED EVENT: A PATIENT HAD GONE BACK TO THE HOSPITAL FOR A FOLLOW UP SURGERY, POST A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE. IT WAS CONFIRMED THAT THE INITIAL PROCEDURE WAS ON (B)(6) 2020 ON SYSTEM SK2477. IT WAS UNKNOWN IF THE CUSTOMER STILL HAD THE INSTRUMENT INVOLVED IN THE PROCEDURE: ENDOWRIST STAPLER 45 INSTRUMENT PN: 470298-12 // LN: T10181211-0076 AND IT WAS CONFIRMED THAT THE SITE DISCARDED THE WHITE AND BLUE RELOADS. IT WAS REPORTED THAT THE SURGEON WAS RESECTING THE TRANSVERSE COLON WHILE FIRING THE STAPLER INSTRUMENT WITH WHITE RELOADS. THEN, WHEN WORKING WITH THE COMMON ENTEROTOMY, THERE WAS A STAPLER FIRE ON THE ILEUM AND ONE PROXIMAL AND SOMEWHERE IN THERE, THE SURGEON, UPSIZED THE RELOAD, POSSIBLY WITH A BLUE. THE SURGEON USED FIREFLY TO MAKE SURE THAT THE TISSUE HAD BLOOD FLOW AND THAT THERE WAS GOOD PERFUSION. IT WAS REPORTED THAT THIS TYPE OF PROCEDURE DOES NOT COMMONLY REQUIRE A LEAK TEST AS ITS USUALLY DONE WITH LEFT HEMICOLECTOMY PROCEDURES, NOT ON THE RIGHT. IT WAS REPORTED THAT THE CASE WAS PROCTORED. ON 11-DEC-2020, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON REGARDING THE REPORTED EVENT: DURING THE INITIAL DA VINCI-ASSISTED RIGHT HEMICOLECTOMY ON (B)(6) 2020, THE SURGEON TRANSECTED THE COLON AND LIGATED ACCORDINGLY USING AN ENDOWRIST STAPLER 45 INSTRUMENT. A PROCTOR WHO WAS PRESENT DURING THE CASE, SUGGESTED USING WHITE VASCULAR RELOADS, TO FIRE AND GET ACROSS THE COLON. THERE WERE THREE SUCCESSFUL FIRES WITH AN ENDOWRIST STAPLER 45 INSTRUMENT AND WHITE VASCULAR RELOADS. THE SURGEON STATED THAT THERE WERE NO SYSTEM ERRORS. THE SYSTEM DID NOT DO ANYTHING UNEXPECTED, THERE WAS NO UNEXPECTED SYSTEM OR INSTRUMENT MOVEMENT, AND ALL INSTRUMENTS AND SYSTEM FUNCTIONALITY WORKED AS INTENDED AND AS EXPECTED. THERE WERE NO CLAMPING OR UNCLAMPING ISSUES AND NO RELOAD STUCK ON TISSUE. THE SURGEON SAID THAT AFTER THE SMALL BOWEL AND COLON WERE TRANSECTED AND EVERYTHING WAS COMPLETED, INDOCYANINE GREEN (ICG) WAS INJECTED FOR FLUORESCENT IMAGING. THE SURGEON AND PROCTOR LOOKED AT BOTH ENDS WITH FIREFLY AND BOTH ENDS, LIT UP BEAUTIFULLY, AS THEY SHOULD HAVE. THE SURGEON THEN STAPLED AN ISOPERISTALTIC ANASTOMOSIS. THE PROCEDURE COMPLETED ROBOTICALLY WITHOUT INCIDENT. THE PATIENT WAS FINE AND DISCHARGED HOME. THE PATIENT HAD CALLED THE CLINIC, EARLIER IN THE WEEK, REQUESTING ADDITIONAL PAIN PILLS FOR INCREASING INCISIONAL PAIN. TEN DAYS AFTER THE ORIGINAL PROCEDURE, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) BY AMBULANCE ON (B)(6) 2020 AND PRESENTED WITH A RIGID ABDOMEN AND WORSENING PAIN. ADDITIONAL UNKNOWN TESTING WAS PERFORMED AND A PERFORATED BOWEL WAS SUSPECTED. AN ON-CALL SURGEON TREATED THE PATIENT AT THE ER. THE FOLLOW-UP SURGEON PERFORMED EMERGENCY EXPLORATORY OPEN SURGERY AND FOUND THAT THE STAPLE LINE ALONG THE TRANSVERSE COLON HAD A 1CM HOLE WHERE THE WHITE LOADS HAD PREVIOUSLY BEEN FIRED. THE SURGEON SAID THAT AFTER SPEAKING WITH THE FOLLOW-UP SURGEON, THE STAPLES HAD OPENED UP. THE FOLLOW-UP SURGEON CUT OUT THE ORIGINAL ANASTOMOSIS AND PERFORMED AN ILEOSTOMY. THE FOLLOW-UP OPEN SURGERY COMPLETED WITHOUT FURTHER COMPLICATION. IT WAS UNKNOWN IF THE ILEOSTOMY WOULD BE NEEDED LONG TERM AS THE PATIENT WAS CURRENTLY IN ICU AND, IS NOT DOING WELL. THE PATIENT WAS REPORTED AS NOT DOING WELL AND MAY GO BACK IN FOR ANOTHER SURGERY DUE TO THE PATIENTS CURRENT WORSENING CLINICAL STATUS AND OVERWHELMING SEPSIS. THERE WAS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT. THE SURGEON BELIEVES THAT THE STAPLE LINE LEAK WAS CAUSED BY HER (THE SURGEON) USING THE WRONG TYPE OF RELOAD THAT THE PROCTOR HAD SUGGESTED USING. SHE SAID SHE SHOULDNT HAVE USED A VASCULAR LOAD. PATIENT DEMOGRAPHICS: (B)(6) YEAR OLD WHITE MALE. THE PATIENT WAS MALNOURISHED AND UNDERWEIGHT AND HAS A HISTORY OF CANCER, CORONARY ARTERY DISEASE, AND HYPERTENSION. ON 14-DEC-2020, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. ISI HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18101	ENDOWRIST	STAPLER 45	NAY	INTUITIVE SURGICAL, INC	470298-12	T10181211 0076	00886874112427

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Death	DA VINCI INSTRUMENTS AND ACCESSORIES