BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 12020333 · Received June 17, 2021

    Report

    Report Number
    1036844-2021-00115
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 24, 2021
    Report Date
    May 31, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    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 IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 50 PC. LOT IN APRIL OF 2020. 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. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE LOOSE AND MISALIGNED AND THE JAW PIVOT PIN IS SLIGHTLY STICKING OUT ONE SIDE OF THE 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 INTERNAL DRIVE ROD (N00185) FINGERS THAT ACTUATE THE JAWS ARE DAMAGED. MISHANDLING OF THIS DEVICE AT THE END USERS 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 USER FOUND MISALIGNMENT OF THE JAWS PRIOR TO USE. THE USER CHECKED THE APPLIER AND FOUND THE PIVOT PIN WAS LOOSE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2020.

    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 USER FOUND MISALIGNMENT OF THE JAWS PRIOR TO USE. THE USER CHECKED THE APPLIER AND FOUND THE PIVOT PIN WAS LOOSE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL IN DECEMEBER 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917166 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06B2098679

    Patients

    Seq Age Sex Outcome Treatment
    1