BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 13342569 · Received January 25, 2022

    Report

    Report Number
    3011137372-2022-00005
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 12, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FOR THE LATE 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 MAY OF 2021. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THERE IS NO DAMAGED TO THE OUTER TUBE ASSEMBLY OR JAW PIVOT PIN AREA AND THE JAWS ARE NOT LOSE OR MISALIGNED IN THE OPEN OR CLOSED POSITIONS. WE ARE UNABLE TO VALIDATE THIS COMPLAINT SINCE WE WERE UNABLE TO FIND ANY NON-CONFORMING FEATURES ON THE RETURNED DEVICE. 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

    SGH COMPLAINED THAT THE APPLIER WAS BENT AFTER PATIENT USED. THE BATCH LOT APPLIER WAS TAKEN OUT FOR INTERNAL HOSPITAL INVESTIGATION. SGH'S BIOMECHANICAL ENGINEER (BME) HAVE FOUND THAT THE PIVOT PIN AT THE APPLIER JAW AREA IS LOOSE AND HAVE HIGH RISK OF LOSING IT OR FALLING INTO PATIENT'S CAVITY DURING SURGICAL PROCEDURE. SGH HAVE SINCE RAISED THE ISSUE TO HIGH AUTHORITY FOR INVESTIGATION.

    Description of Event or Problem · 0

    SGH COMPLAINED THAT THE APPLIER WAS BENT AFTER PATIENT USED. THE BATCH LOT APPLIER WAS TAKEN OUT FOR INTERNAL HOSPITAL INVESTIGATION. SGH'S BIOMECHANICAL ENGINEER (BME) HAVE FOUND THAT THE PIVOT PIN AT THE APPLIER JAW AREA IS LOOSE AND HAVE HIGH RISK OF LOSING IT OR FALLING INTO PATIENT'S CAVITY DURING SURGICAL PROCEDURE. SGH HAVE SINCE RAISED THE ISSUE TO HIGH AUTHORITY FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688090 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06C2000255 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown