BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 13587157 · Received February 23, 2022

    Report

    Report Number
    3011137372-2022-00033
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 14, 2022
    Report Date
    February 14, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 50 PC. LOT IN APRIL OF 2020. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE LOOSE AND MISALIGNED, AND THE JAW PIVOT PIN IS SLIGHTLY STICKING OUT OF ONE SIDE OF THE OUTER TUBE ASSEMBLY. FURTHER EVALUATION SHOWS THAT THE KNOB ROTATION MECHANISM IS DRY AND SLUGGISH FEELING AND IN NEED OF PROPER LUBRICATION. 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) BOSSES ARE BOTH DAMAGED WHERE THEY ENGAGE THE JAWS. WE SUSPECT THAT THE DAMAGED DRIVE ROD BOSSES CAUSED THE JAWS TO BECOME SLIGHTLY LOOSE AND MISALIGNED IN THE CLOSED POSITION. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE DRIVE ROD BOSSES TO BECOME DAMAGED BUT 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 JAWS WERE FOUND MISALIGNED AND THE PIVOT PIN WAS LOOSE WHEN THE APPLIER WAS CLEANED AND STERILIZED AFTER A SURGERY.

    Description of Event or Problem · 0

    THE JAWS WERE FOUND MISALIGNED AND THE PIVOT PIN WAS LOOSE WHEN THE APPLIER WAS CLEANED AND STERILIZED AFTER A SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820252 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06B2098679 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown