BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 12127665 · Received July 7, 2021

    Report

    Report Number
    3011137372-2021-00175
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 29, 2021
    Report Date
    June 29, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY NONCONFORMANCE'S NOTED OR IRREGULARITIES. IT WAS ALSO FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS. IT CAN THEN BE STATED THAT THE ALLEGED NON-CONFORMANCE INCITING THIS COMPLAINT WAS NOT DUE TO AN ERROR IN TECOMET - KENOSHA'S MANUFACTURING PROCESS. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A (B)(4) PC. LOT IN MAY OF 2020. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE SLIGHTLY LOOSE AND MISALIGNED , AND THE JAW PIVOT PIN IS SLIGHTLY STICKING OUT OF ONE SIDE OF THE OUTER TUBE ASSEMBLY. WE ARE ABLE TO VALIDATE THIS COMPLAINT. THERE ARE NO COMPONENTS MISSING FROM THE RETURNED APPLIER. 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. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE JAW PIVOT PIN TO BE SLIGHTLY STICKING OUT OF THE OUTER TUBE ASSEMBLY AND FOR THE DRIVE ROD FINGERS TO BECOME DAMAGED BUT MISHANDLING OF THIS DEVICE 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 PIVOT PIN WAS FOUND LOOSE WHEN A NURSE CHECKED THE MOVEMENT OF THE APPLIER DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS SENT TO THE HOSPITAL IN (B)(6) 2021, AS A REPLACEMENT OF A DEFECTIVE PRODUCT.

    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 PIVOT PIN WAS FOUND LOOSE WHEN A NURSE CHECKED THE MOVEMENT OF THE APPLIER DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS SENT TO THE HOSPITAL IN (B)(6) 2021, AS A REPLACEMENT OF A DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029091 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06B2098686 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1