BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 17695696 · Received September 6, 2023

    Report

    Report Number
    9610877-2023-00216
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    July 31, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT CLINICAL CODE: 3165 DEVICE EMBEDDED IN TISSUE OR PLAQUE 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: 10 TESTING OF ACTUAL/SUSPECTED DEVICE, 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 RETURNED CAP[DEC] WAS INSPECTED AT PENTAX MEDICAL CANADA AND WAS IN NEW CONDITION REVEALING THAT IS WAS NOT ATTACHED CORRECTLY. THE DUODENOSCOPE WAS INSPECTED ON AUG 18, 2023, AND THE STERILE DISTAL END CAP DIAMETER AND OTHER SPECIFICATIONS WERE WITHIN THE MANUFACTURER'S SPECIFICATIONS, SO WE WERE ABLE TO TEST ANY OE-A63 AND IT WAS CONNECTING AND DISCONNECTING FINE. THE DUODENOSCOPE HAS BEEN RETURNED TO THE USER FACILITY ON AUG 24, 2023. 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 DUODENOSCOPE WAS MANUFACTURED BY PENTAX MEDICAL MIYAGI ON 28-SEP-2020 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 28-SEP-2020. PATIENT CONDITION STATUS WAS PROVIDED ON 31-OCT-2023 BY PCI AND PATIENT IS NOTED AS FINE AND NO FURTHER REPORTS OR CONCERNS WERE RECEIVED. MANUFACTURER MDR 9610877-2023-00198, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0031102, (B)(6) 2023 PROCEDURE MANUFACTURER MDR 9610877-2023-00216, 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, 08-AUG-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.

    Additional Manufacturer Narrative · 0

    H6 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING; HEALTH EFFECT CLINICAL CODE: 3165 DEVICE EMBEDDED IN TISSUE OR PLAQUE. 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. 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. LODGED BETWEEN VOCAL CORDS. SINCE THE PATIENT WAS NOT WEARING AN INTUBATION TUBE AT THE TIME OF THE ENDOSCOPY, THE PATIENT WAS ALLOWED TO BITE THE MOUTHPIECE AND A NORMAL ENDOSCOPY WAS PERFORMED. WHAT HAPPENED TO THE PATIENT (ACTUAL OR POTENTIAL CLINICAL CONSEQUENCES FROM THE EVENT, PATIENT OUTCOME, CURRENT PATIENT STATUS)? PATIENT STATUS IN UNKNOWN AT THIS POINT. WHAT PROCEDURE WAS INVOLVED? ERCP PROCEDURE. WHAT ACTIONS HAVE BEEN TAKEN TO CORRECT THE ISSUE? BX FORCEPS AND A BASKET WERE USED TO REMOVE THE CAP. WHEN WAS IT FIRST OBSERVED - THE FIRST EVENT WAS (B)(6) 2023 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 18-AUG-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 FIELD CORRECTIVE ACTION(FCA) WHICH WAS CONDUCTED BY PENTAX MEDICAL WHICH INCLUDED TRAINING ON THE CORRECT USE, AND PRE-CASE CHECK. ON 25-AUG-2023 TRAINING RECORDS FROM HOSPITAL HAVE BEEN REQUESTED BY THE FIELD REP. THE ENDOSCOPE (S/N (B)(6)) HAS BEEN RECEIVED. INSPECTION REVEALED DISTAL END DIAMETER WITHIN SPEC. A QUICK REFERENCE DOCUMENT (DOS, DONTS) IS BEING PREPARED TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2023 THAT OCCURRED IN THE ENDOSCOPY SUITE DURING USE IN CANADA ON (B)(6) 2023. THE CUSTOMER REPORTED THAT A STERILE SINGLE USE DISTAL END CAP(DEC), MODEL OE-A63, LOT NUMBER 0031102, CAME OFF DURING INTUBATION AND THEY SWITCHED TO A GASTROSCOPE. THE DEC WAS LODGED BETWEEN THE VOCAL CORDS. HENCE, BX [BIOPSY] FORCEPS AND A BASKET WERE USED TO REMOVE AND RETRIEVE THE CAP. THE MANUFACTURER AND MODEL OF THE FORCEPS AND BASKET WERE NOT PROVIDED. THE STERILE SINGLE USE DISTAL END CAP(DEC) WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT STATUS IN UNKNOWN AT THIS POINT. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(6). 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
    974748 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333233007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention