BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 12727910 · Received November 1, 2021

    Report

    Report Number
    3011137372-2021-00310
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 15, 2021
    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 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 (B)(4) PC. LOT IN JUNE OF 2020. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE BENT TO ONE SIDE AND LOOSE AND MISALIGNED, (PIE'S ATTACHED) AND THE JAW PIVOT PIN IS PUSHED THRU ONE SIDE OF THE DAMAGED/BENT OUTER TUBE ASSEMBLY. 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) IS BENT/DAMAGED, AND ITS BOSSES ARE BOTH DAMAGED WHERE THEY ENGAGE THE JAWS. WE ARE UNABLE TO DETERMINE HOW THE DRIVE ROD (N00185) BECAME BENT/DAMAGED AND FOR THE DRIVE ROD BOSSES TO BECOME DAMAGED AND FOR THE JAWS TO BECOME LOOSE AND MISALIGNED AND FOR THE JAW PIVOT PIN TO BE PUSHED THRU ONE SIDE OF THE OUTER TUBE ASSEMBLY BUT MISHANDLING AT THE END USER'S FACILITY IS SUSPECTED. ALL (B)(4) 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 BROKEN DURING A PRETEST BEFORE USE. ALSO, THE PIVOT PIN WAS DETACHED. THE APPLIER WERE PURCHASED BY THE HOSPITAL WITHIN 1 YEAR.

    Additional Manufacturer Narrative · 1

    QN#: (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 JAWS WERE FOUND BROKEN DURING A PRETEST BEFORE USE. ALSO, THE PIVOT PIN WAS DETACHED. THE APPLIER WERE PURCHASED BY THE HOSPITAL WITHIN 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630576 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06B2098690 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown