BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 10555497 · Received September 18, 2020

    Report

    Report Number
    2518897-2020-00155
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    August 14, 2020
    Report Date
    April 20, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION. B4: DATE OF THIS REPORT. B5.REFER TO H10. F7: FOLLOW UP #01. F11: UPDATED DATES. F13: UPDATED DATES. ADDITIONAL INFORMATION D4: UNIQUE IDENTIFIER (UDI) ADDED. F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING HEALTH EFFECT IMPACT CODE: 2199 NO HEALTH CONSEQUENCES OR IMPACT COMPONENT CODE: 424 CAP. ON 24-SEP-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL OE-A63, SERIAL NUMBER (B)(6) WAS PERFORMED UNDER IVAI-20-090030. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED AT THE HINAI CLOCK, OKINAWA FACILITY ON 26-DEC-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 FOR 10-JAN-2020. AS A RESULT OF THE INTERNAL INVESTIGATION PERFORMED BY THE MANUFACTURER UNDER A CAPA, IT WAS DETERMINED THE DISTAL END CAP(DEC) BEING DISLODGED WAS NOT RELATED TO DESIGN OR MANUFACTURING. IT WAS DETERMINED THAT IMPROVED TRAINING AND CLARIFICATION OF LABELING (IFUS) WOULD BE HELPFUL IN ENSURING PROPER ATTACHMENT AND CONTINUED SAFE USE OF THE DEVICE. REFER TO RESOLUTION SECTION FOR ADDITIONAL DETAILS. AS A RESULT OF THE DEC INVESTIGATION AND ASSOCIATED CAPA, PENTAX HAS UPDATED THE LABELING (BOTH THE DISTAL END CAP IFU AND THE DUODENOSCOPE IFU) FOR ED34-I10T2. THE INSTRUCTIONS WERE UPDATED TO INCLUDE ADDITIONAL WORDING AND ILLUSTRATIONS TO HELP ENSURE A MORE SECURE ATTACHMENT OF THE DISTAL END CAP. IN ADDITION, THE WARNING SECTION OF THE IFUS HAVE BEEN UPDATED TO NOTIFY USERS OF THE ASSOCIATED RISKS WITH THE DISTAL END CAP (OE-A63) UNEXPECTEDLY BECOMING DETACHED DURING A PROCEDURE. THE UPDATE ALSO NOTIFIES USERS OF WHAT IMMEDIATE ACTIONS SHOULD BE TAKEN IN CASE THE EVENT OCCURS. THESE CHANGES WERE CLEARED IN 510(K) K210710 AND DISTRIBUTED TO THE INSTALLED BASE VIA A 21 CFR 806.10 FIELD CORRECTIVE ACTION (2021-004-C). IN ADDITION, A QUICK REFERENCE GUIDE UTILIZING EXISTING LABELING WAS CREATED, LAMINATED AND ATTACHED TO VIDEO PROCESSOR CARTS AT ALL US CUSTOMERS OF THE ED34-I10T2. TRAINING TO THE QUICK REFERENCE GUIDE WAS COMPLETED AT ALL SITES, AND AN INSTRUCTIONAL VIDEO WAS PRODUCED AND HAS BEEN DISTRIBUTED TO ALL SITES. THE IN-SERVICE VIDEO PROVIDES INSTRUCTIONS ON PROPER ATTACHMENT OF THE DISPOSABLE END CAP TO ED34-I10T2 WAS CREATED AND DISTRIBUTED VIA SHOWPAD AND PENTAX YOUTUBE. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    REFER TO H10

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. A NURSE FROM THE USER FACILITY REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO PASS A BIOPSY FORCEP DURING ERCP CASE WHEN IT DISLODGED THE DISTAL END CAP WHILE INSIDE PATIENT, INVOLVING A PENTAX MEDICAL ACCESSORY MODEL OE-A63, LOT #0011010, USED WITH A PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(4). THE SALES REP RESPONDED WITH ADDITIONAL EVENT DETAILS VIA EMAIL ON 28-AUG-2020 IN RESPONSE TO THE COMPLAINT HANDLING UNIT GOOD FAITH EFFORT. THE SALES REP CONFIRMED THE DISTAL END CAP(DEC) BEING DISLODGED AND FELL INTO THE PATIENT WHILE THE PHYSICIAN WAS PASSING AN UNKNOWN BIOPSY FORCEPS DURING A TREATMENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) CASE. THE DISTAL END CAP WAS QUICKLY RETRIEVED AND A NEW DEC, SAME LOT NUMBER 0011010, WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY, AND THE DUODENOSCOPE REMAINED IN CIRCULATION. PATIENT INFORMATION WAS REQUESTED BUT NOT AVAILABLE FROM THE FACILITY. THE FACILITY DOES PERFORM PRE-PROCEDURAL CHECKS AND USE FOR THE PRODUCT INVOLVED AS WELL AS ACCESSORY AND REPROCESSING INSTRUCTIONS FOR USE(IFUS). THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021009 PENTAX STERILE DISTAL END CAP FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0011010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other