BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 11382541 · Received February 25, 2021

    Report

    Report Number
    2518897-2021-00038
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 24, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: F7: FOLLOW UP #01. ALTHOUGH REVIEW OF REPRESENTATIVE PRODUCTS DID NOT HELP IDENTIFY THE ROOT CAUSE, AS A RESULT OF THE INTERNAL INVESTIGATION PERFORMED BY THE MANUFACTURER UNDER CAPA NUMBER CAPA-PAI-21-030117, 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 (OEA63) 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 CFR806.10 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 · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 26-JAN-2021 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THE DISPOSABLE DEC [DISTAL END CAP] BECAME DISLODGED DURING PROCEDURE AND THE DEC CAP WAS LOCATED AND FOUND WITHIN THE PATIENTS MOUTH, INVOLVING PENTAX MEDICAL STERILE DISTAL END CAP ACCESSORY, MODEL OE-A63, LOT NUMBER 0011040. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. ALTHOUGH THE STERILE DISTAL END CAP ACCESSORY USED IN THE PROCEDURE IS NOT BEING RETURNED FOR EVALUATION, TWO SIMILAR LOT DECS, LOT NUMBER 0011040 WERE RETURNED TO PENTAX MEDICAL ON 08-FEB-2021 AND ARE BEING SENT TO THE MANUFACTURER FOR INVESTIGATION. THE ENDOSCOPE SERIAL NUMBER WAS REQUESTED VIA GOOD FAITH EFFORTS ATTEMPTS VIA EMAIL ON 28-JAN-2021, 08-FEB-2021, AND ON 25-FEB-2021. ON 02-DEC-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR PENTAX MEDICAL ACCESSORY MODEL OE-A63, LOT #0011040 WAS PERFORMED UNDER IVAI-20-110107, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 15-APR-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 FOR (B)(6) 2020. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277880 PENTAX STERILE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0011040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other