BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 12085156 · Received June 29, 2021

    Report

    Report Number
    3011137372-2021-00163
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 18, 2021
    Report Date
    June 18, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY NONCONFORMANCE'S OR IRREGULARITIES. IT WAS ALSO FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS. THIS INSTRUMENT WAS PRODUCED ON SHOP ORDER 50289610 AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 50-PIECE LOT IN MARCH OF 2020. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE JAWS ARE LOOSE AND MISALIGNED , AND THE JAW PIVOT PIN IS PULLED THRU ONE SIDE OF THE BENT/DAMAGED OUTER TUBE ASSEMBLY AND THE DRIVE ROD (N00185) IS ALSO BENT/DAMAGED IN THE AREA THAT IT ENGAGES THE JAWS. WE ARE ABLE TO VALIDATE THIS COMPLAINT. AFTER THE INITIAL EVALUATION THIS INSTRUMENT WAS DIS-ASSEMBLED IN ORDER TO EVALUATE ITS INTERNAL COMPONENTS AND IT WAS FOUND THAT THE INNER DRIVE ROD (N00185) FINGERS ARE BOTH DAMAGED WHERE THEY ENGAGE THE JAWS. MISHANDLING OF THIS DEVICE AT THE END USER'S FACILITY IS SUSPECTED. ALL 50 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS , NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED.

    Description of Event or Problem · 0

    THE PIVOT PIN GOT DETACHED DURING A SURGERY. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE. NOTHING FELL/REMAINED IN THE PATIENT. THE APPLIER WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE PIVOT PIN GOT DETACHED DURING A SURGERY. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE. NOTHING FELL/REMAINED IN THE PATIENT. THE APPLIER WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979306 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06F1989610 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1