BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 14239148 · Received April 28, 2022

    Report

    Report Number
    3011137372-2022-00072
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 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

    QN#: (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    QN#(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 MARCH OF 2020. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE LOOSE AND MISALIGNED, AND THE JAW PIVOT PIN IS PUSHED/PULLED INTO ONE SIDE OF THE DAMAGED OUTER TUBE ASSEMBLY. WE ARE ABLE TO VALIDATE THIS COMPLAINT. THE OUTER CHAMFER OF THE RIVET THRU HOLE WHERE THE RIVET WAS PUSHED/PULLED INTO WAS MEASURED USING A VISION SYSTEM AND IT MEASURES TO PRINT SPECIFICATIONS OF 0.078 +.002/-.006 @ .073". 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 BECOME DAMAGED AND FOR THE JAW PIVOT PIN TO BE PUSHED I PULLED INTO ONE SIDE OF THE OUTER TUBE ASSEMBLY 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 BEFORE USE. THE APPLIER WAS PURCHASED BY THE HOSPITAL 13 MONTHS AGO BUT WAS ACTUALLY USED FOR LESS THAN 1 YEAR.

    Description of Event or Problem · 0

    THE JAWS WERE FOUND MISALIGNED AND THE PIVOT PIN WAS LOOSE BEFORE USE. THE APPLIER WAS PURCHASED BY THE HOSPITAL 13 MONTHS AGO BUT WAS ACTUALLY USED FOR LESS THAN 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59555 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06F1989611 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown