BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 6773699 · Received August 8, 2017

    Report

    Report Number
    3003898360-2017-00835
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 19, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K152081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PMA/510(K)# IS K021808.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACILITY HAS COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML, LOT #73L1600101 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME BECAUSE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE CLIP WOULD FIRE THEN SOME WOULD MISFIRE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    THE CLIP WOULD FIRE THEN SOME WOULD MISFIRE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555887 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL 73L1600101

    Patients

    Seq Age Sex Outcome Treatment
    1