BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 12569016 · Received October 4, 2021

    Report

    Report Number
    3011137372-2021-00259
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 21, 2021
    Report Date
    September 22, 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 OHR 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-PIECE LOT IN MARCH OF 2020. EVALUATION OF THE RETURNED DEVICE AS RECEIVED SHOWS THAT THE JAWS ARE SLIGHTLY LOOSE AND MISALIGNED TO EACH OTHER IN THE CLOSED POSITION AND IT HAS A NON-TELEFLEX LUER FLUSH FORT CAP INSTALLED ON THE LUER FLUSH PORT. WE ARE ABLE TO VALIDATE THIS COMPLAINT SINCE THE JAWS ARE NOT ALIGNED IN THE CLOSED POSITION AND THAT COULD MAKE IT DIFFICULT TO CLOSE A CLIP. 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. (PIE'S ATTACHED) 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 ECOME 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 OMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED.

    Description of Event or Problem · 0

    WHEN THE USER ATTEMPTED TO LIGATE A CLIP DURING A SURGERY, HE/SHE DID NOT HEAR THE USUAL CLICKING SOUND AND FELT SOMETHING DIFFERENT. HE/SHE REMOVED THE APPLIER FROM THE PATIENT AND TESTED TO LIGATE THEN SOME CLIPS WERE NOT LOCKED PROPERLY. HE/SHE REPLACED THE APPLIER WITH ANOTHER ONE BY WHICH WAS ABLE TO LIGATE AND COMPLETE THE SURGERY. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 6 MONTHS.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    WHEN THE USER ATTEMPTED TO LIGATE A CLIP DURING A SURGERY, HE/SHE DID NOT HEAR THE USUAL CLICKING SOUND AND FELT SOMETHING DIFFERENT. HE/SHE REMOVED THE APPLIER FROM THE PATIENT AND TESTED TO LIGATE THEN SOME CLIPS WERE NOT LOCKED PROPERLY. HE/SHE REPLACED THE APPLIER WITH ANOTHER ONE BY WHICH WAS ABLE TO LIGATE AND COMPLETE THE SURGERY. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469284 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06F1989611 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown