BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 10864769 · Received November 18, 2020

    Report

    Report Number
    3011137372-2020-00258
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    July 31, 2020
    Report Date
    November 5, 2020
    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 JUNE OF 2019. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE JAW PIVOT PIN IS SLIGHTLY POPPED OUT ON ONE SIDE OF THE OUTER TUBE ASSEMBLY AND THE TIPS ARE SLIGHTLY LOOSE AND MISALIGNED AS STATED IN THE COMPLAINT. FURTHER EVALUATION SHOWS THAT HAS RECEIVED THIS INSTRUMENT HAS A NON-TELEFLEX LUER FLUSH PORT CAP INSTALLED ON IT AND THE PIVOT SCREW (N00186) THAT HOLDS THE HANDLE ASSEMBLY TOGETHER WAS ALSO SLIGHTLY BACKED OUT OF THE G00436M PROXIMAL HANDLE. THIS INSTRUMENT WAS DISASSEMBLED FOR FURTHER EVALUATION AND IT WAS FOUND THAT THE INTERNAL DRIVE ROD (N00185) FINGERS ARE ALSO DAMAGED. WE ARE ABLE TO VALIDATE THIS COMPLAINT. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE INTERNAL DRIVE ROD FINGERS TO BECOME DAMAGED BUT WE SUSPECT THAT THIS IS WHAT CAUSED THE JAW PIVOT PIN TO BECOME SLIGHTLY PUSHED OUT OF THE TUBE ASSEMBLY AND FOR THE JAWS TO BECOME SLIGHTLY LOOSE AND MISALIGNED. THIS DEVICE SHOWS SIGNS OF INTERNAL DAMAGE THEREFORE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLIP FELL FROM THE APPLIER WHEN THE USER ATTEMPTED TO LIGATE DURING A SURGERY. THE FALLEN CLIP WAS PICKED UP AND TAKEN OUT OF THE PATIENT BODY. THE USER SUSPECTED THE MISALIGNMENT OF THE JAWS SO THAT REPLACED THE APPLIER WITH A NEW ONE TO COMPLETE THE SURGERY. THE APPLIER WAS PURCHASED BY THE HOSPITAL ON (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

    IT WAS REPORTED THAT A CLIP FELL FROM THE APPLIER WHEN THE USER ATTEMPTED TO LIGATE DURING A SURGERY. THE FALLEN CLIP WAS PICKED UP AND TAKEN OUT OF THE PATIENT BODY. THE USER SUSPECTED THE MISALIGNMENT OF THE JAWS SO THAT REPLACED THE APPLIER WITH A NEW ONE TO COMPLETE THE SURGERY. THE APPLIER WAS PURCHASED BY THE HOSPITAL ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328364 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06K1878150

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.