PENTAX
Report
- Report Number
- 9610877-2023-00217
- Event Type
- Injury
- Date Received
- September 6, 2023
- Date of Event
- August 8, 2023
- Report Date
- November 16, 2023
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDT
- UDI-DI
- 04961333233007
- PMA / PMN Number
- K192245
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 2687 FOREIGN BODY IN PATIENT (HEALTH EFFECT CLINICAL CODE, 2687 FOREIGN BODY IN PATIENT, WAS SELECTED EVEN THOUGH THE DEC WAS NOT RETRIEVED FROM INSIDE THE PATIENT BY THE USER, BUT THE DEC WAS THOUGHT TO HAVE COME OFF INSIDE THE PATIENT'S MOUTH AND GRABBED BY THE PATIENT.) HEALTH EFFECT IMPACT CODE: 4638 ENDOSCOPIC PROCEDURE, 4642 ADDITIONAL DEVICE REQUIRED, 4604 DELAY TO TREATMENT/THERAPY. MEDICAL DEVICE PROBLEM CODE: 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT. COMPONENT CODE: 424 CAP. TYPE OF INVESTIGATION: 3331 ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS: 4248 USAGE PROBLEM IDENTIFIED. INVESTIGATION CONCLUSIONS: 27 CAUSE TRACED TO TRAINING, 19 CAUSE TRACED TO USE. EVALUATION SUMMARY: THE DUODENOSCOPE DID NOT REQUIRE TO BE RETURNED FOR FURTHER INSPECTION AS IT IS WORKING FINE WITH OTHER STERILE DISTAL END CAPS OF THE SAME LOT NUMBER. PENTAX MEDICAL CANADA HAS CONFIRMED BY EMAIL THAT THE CUSTOMER CONFIRMED VERBALLY THAT TRAINING WAS CONDUCTED TO ADDRESS THE USER RELATED ERROR. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED PENTAX MEDICAL MIYAGI ON 08-JAN-2019 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 08-JAN-2019. MANUFACTURER MDR 9610877-2023-00198, DEC DISTAL CAP MODEL OE-A63, LOT NUMBER 0031102, 31-JUL-2023 PROCEDURE. MANUFACTURER MDR 9610877-2023-00216, DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(6), 31-JUL-2023 PROCEDURE. MANUFACTURER MDR 9610877-2023-00197, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0031102, (B)(6) 2023 PROCEDURE MANUFACTURER MDR 9610877-2023-00217, DUODENOSCOPE MODEL ED34-I10T2 SERIAL NUMBER (B)(6), (B)(6) 2023 PROCEDURE. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.
H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 2687 FOREIGN BODY IN PATIENT (HEALTH EFFECT CLINICAL CODE, 2687 FOREIGN BODY IN PATIENT, WAS SELECTED EVEN THOUGH THE DEC WAS NOT RETRIEVED FROM INSIDE THE PATIENT BY THE USER, BUT THE DEC WAS THOUGHT TO HAVE COME OFF INSIDE THE PATIENT'S MOUTH AND GRABBED BY THE PATIENT.) HEALTH EFFECT IMPACT CODE: 4638 ENDOSCOPIC PROCEDURE, 4642 ADDITIONAL DEVICE REQUIRED, 4604 DELAY TO TREATMENT/THERAPY. MEDICAL DEVICE PROBLEM CODE: 2907 DETACHMENT OF DEVICE OR DEVICE COMPONENT. COMPONENT CODE: 424 CAP. TYPE OF INVESTIGATION: 4118 TYPE OF INVESTIGATION NOT YET DETERMINED INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION INVESTIGATION CONCLUSIONS: 11 CONCLUSION NOT YET AVAILABLE. PENTAX MEDICAL PAI RECEIVED A GOOD FAITH EFFORT(GFE) RESPONSE. DETAILS BELOW. PATIENT WAS RECALLED FOR FURTHER SCREENING. BRONCHOSCOPY WAS PERFORMED ON (B)(6) 2023. CURRENT STATUS OF PATIENT: DISCHARGED /HOME. WHO WAS INVOLVED (CLINICIAN, TECHNICIAN, PATIENT, OTHER) - PATIENT. WHAT HAPPENED TO THE DEVICE (HOW DID THE DEVICE FAIL TO MEET ITS INTENDED USE OR USER EXPECTATION) - CAP CAME OFF DURING INTUBATION, SWITCHED TO GASTROSCOPE. WHAT HAPPENED TO THE PATIENT (ACTUAL OR POTENTIAL CLINICAL CONSEQUENCES FROM THE EVENT, PATIENT OUTCOME, CURRENT PATIENT STATUS), HOSPITAL HAD TO CALL RESPIROLOGY. CURRENT STATUS OF PATIENT: DISCHARGED / HOME. WHAT PROCEDURE WAS INVOLVED - ERCP PROCEDURE. WHAT ACTIONS HAVE BEEN TAKEN TO CORRECT THE ISSUE - THEY CALLED IN RESPIROLOGY TO FIND THE CAP AND RESPIROLOGY COULD NOT FIND THE CAP. AS THEY WERE TENDING TO THE PATIENT, THEY FOUND IT IN THE PATIENTS HAND. HOWEVER, THEY BELIEVE IT WAS IN HER MOUTH AND SHE HAD GRABBED IT OUT, AS THIS PATIENT WAS GRASPING AT HER MOUTH A LOT. WHEN WAS IT FIRST OBSERVED - THE FIRST EVENT WAS (B)(6) AND SECOND EVENT IS (B)(6) 2023. WHERE IN THE FACILITY DID IT HAPPEN - ENDOSCOPY DEPARTMENT. WHERE WAS IT FIRST OBSERVED - DURING PROCEDURE IN ENDOSCOPY. HOW DID IT HAPPEN (IF KNOWN) - UNKNOWN AT THIS POINT. WAS THE PROCEDURE FOR TREATMENT OR DIAGNOSTIC PURPOSES. TREATMENT WAS THERE A DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION SUCH AS ADDITIONAL ANESTHESIA OR PROLONGED HOSPITAL STAY. YES. DID A NURSE ATTACH THE CAP# OE-A63 TO THE DISTAL PART OF THE ENDOSCOPE. IF SO, DID THEY HEAR THE CLICKING SOUND WHEN ATTACHING IT. YES. ON (B)(6) 2023, THE DUODENOSCOPE WAS DETERMINED TO BE A PCI LOANER AND REMAINS IN USE AT (B)(6) SITE. PENTAX FIELD REP CONFIRMED THAT NEW NURSES WERE WORKING DURING THIS INCIDENT. THE FIELD REP HAS PROVIDED ADDITIONAL TRAINING ON THE PROPER USE AND PRE-CASE CHECK OF THE ELEVATOR CAP(DEC) TO THE NEW NURSES. THE FIELD REP HAS CONFIRMED THE HOSPITAL STAFF IS AWARE OF, AND THE NEW STAFF HAVE NOW BEEN TRAINED, ON THE 2021 FIELDCORRECTIVE ACTION (FCA) WHICH WAS CONDUCTED BY PENTAX MEDICAL WHICH INCLUDED TRAINING ON THE CORRECT USE, AND PRE-CASE CHECK. ON (B)(6) 2023 TRAINING RECORDS FROM HOSPITAL HAVE BEEN REQUESTED BY THE FIELD REP. PENTAX CANADA INC.(PCI) DETERMINED THE DUODENOSCOPE DOES NOT NEED TO BE RETURNED FOR EVALUATION. ADDITIONALLY, A QUICK REFERENCE DOCUMENT IS BEING PREPARED TO ADDRESS THIS ISSUE.(CURRENTLY IN DRAFT). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MANUFACTURER MDR 9610877-2023-00198, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0031102, (B)(6) 2023 PROCEDURE. MANUFACTURER MDR 9610877-2023-00217, DUODENOSCOPE MODEL ED34-I10T2 SERIAL NUMBER (B)(6), (B)(6) 2023 PROCEDURE. MANUFACTURER MDR 9610877-2023-00197, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0031102, (B)(6) 2023 PROCEDURE. MANUFACTURER MDR 9610877-2023-00218, DUODENOSCOPE MODEL ED34-I10T2 SERIAL NUMBER (B)(6), (B)(6) 2023 PROCEDURE.
PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2023 THAT OCCURRED IN THE ENDOSCOPY SUITE DURING USE IN CANADA. THE CUSTOMER REPORTED THAT A STERILE SINGLE USE DISTAL END CAP(DEC), MODEL OE-A63, LOT NUMBER 0031102, CAME OFF DURING INTUBATION DURING THE ERCP(ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(6). THE RESPIROLOGY TEAM WAS BROUGHT IN TO FIND THE DEC AND RESPIROLOGY WAS UNABLE TO FIND THE DEC. AS THE CUSTOMER WAS TENDING TO THE PATIENT, THEY FOUND THE DEC IN THE PATIENTS HAND. THEY BELIEVE IT WAS DISLODGED INSIDE HER MOUTH AND SHE HAD GRABBED IT OUT, AS THIS PATIENT WAS GRASPING AT HER MOUTH A LOT DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME. OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) WAS SELECTED SINCE THE ACTIONS OF THE RESPIROLOGY TEAM DID NOT LOCATE THE DETACHED DEC AND NO ACTIONS WERE NEEDED TO RECOVER THE DEC BASED ON CUSTOMER RESPONSES. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1209816 | PENTAX | VIDEO DUODENOSCOPE | FDT | HOYA CORPORATION PENTAX TOKYO OFFICE | ED34-I10T2 | 04961333233007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |