BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON ANG 6MM CUP FCPS 28CM

    MDR report key: 15550565 · Received October 6, 2022

    Report

    Report Number
    3011137372-2022-00196
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    August 19, 2022
    Report Date
    September 20, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JEK
    UDI-DI
    24026704530643
    PMA / PMN Number
    K990561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED. THESE INSTRUMENTS FEATURE A REMOVEABLE HANDLE WHICH MUST BE PROPERLY REASSEMBLED. REMOVAL OF THE HANDLE IS NOT REQUIRED FOR CLEANING AND SHOULD ONLY BE PERFORMED BY QUALIFIED TECHNICIANS. INCORRECT ASSEMBLY OF THE HANDLE RESULTS IN FAILURE TO FUNCTION AND UNEXPECTED DISASSEMBLY WHEN THE RETAINING TAB IS NOT CORRECTLY SEATED. PROPER ASSEMBLY CAN BE EASILY CONFIRMED BY LOOKING AT THE HANDLE/TAB AND SLOT INTERFACE. THE DEVICE HAS BEEN VALIDATED FOR STERILIZATION WITHOUT DISASSEMBLY. IF THE SAMPLE IS RECEIVED IT CAN BE REASSEMBLED AND RETURN TO THE CUSTOMER. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE ANGLED CUP BITER WAS BEING USED BY THE DOCTOR TO OBTAIN A LYMPH NODE BIOPSY. HANDLE OF BITER CAME APART WHILE IN USE. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE FIELD. X-RAY WAS OBTAINED PRIOR TO SURGICAL INCISION CLOSURE. ABSENCE OF RETAINED OBJECT WAS VERIFIED BY THE DOCTOR AND RADIOLOGIST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANGLED CUP BITER WAS BEING USED BY THE DOCTOR TO OBTAIN A LYMPH NODE BIOPSY. HANDLE OF BITER CAME APART WHILE IN USE. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE FIELD. X-RAY WAS OBTAINED PRIOR TO SURGICAL INCISION CLOSURE. ABSENCE OF RETAINED OBJECT WAS VERIFIED BY THE DOCTOR AND RADIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236539 JACKSON ANG 6MM CUP FCPS 28CM FORCEPS, GENERAL & PLASTIC SUR JEK TELEFLEX MEDICAL IPN007777 24026704530643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention