BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 8678996 · Received June 7, 2019

    Report

    Report Number
    3003898360-2019-00667
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 15, 2019
    Manufacturer
    TELEFLEX MEDICAL/MORRISVILLE
    Product Code
    FZP
    PMA / PMN Number
    K021808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE UNIT OF 543965 AUTOENDO5 ML FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE BY ATTEMPTING TO ENGAGE THE TRIGGER USING HAND PRESSURE. UPON ENGAGEMENT OF THE TRIGGER, AN AUDIBLE RATCHET SOUND WAS HEARD INDICATING THAT THE INTERNAL RATCHET EARS ARE INTACT. THE FIRST CLIP WAS ABLE TO PROPERLY LOAD INTO THE JAWS OF THE APPLIER AND WAS SUCCESSFULLY APPLIED TO OVER-STRESSED SURGICAL TUBING. THE REMAINING CLIPS WERE ALSO ABLE TO BE SUCCESSFULLY APPLIED TO OVER-STRESSED SURGICAL TUBING. THE SAMPLE WAS RECEIVED WITH 10 CLIPS REMAINING IN THE CHANNEL INDICATING THAT 5 CLIPS WERE FIRED BY THE END USER. NO DEFECTS OR ANOMALIES WERE OBSERVED. THE IFU FOR THIS PRODUCT, L03496, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT STATES, "MISHANDLING OF APPLIERS MAY RESULT IN IMPROPER LOAD AND/OR CLOSURE OF THE LIGATING CLIP." THE REPORTED COMPLAINT OF "CLIPS NOT CLOSING PROPERLY" WAS NOT CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONE DEVICE WAS RETURNED. UPON FUNCTIONAL INSPECTION, NO PROBLEMS WERE FOUND AS THE REMAINING CLIPS WERE ABLE TO LOAD PROPERLY INTO THE JAWS AND WERE SUCCESSFULLY APPLIED TO OVER-STRESSED SURGICAL TUBING. THE DEVICE WAS RECEIVED WITH 10 CLIPS REMAINING IN THE CHANNEL INDICATING THAT THE END USER FIRED 5 CLIPS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE APPLIER IT WAS IMPOSSIBLE TO TIGHTEN THE CLIPS AND LOCK THEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE APPLIER IT WAS IMPOSSIBLE TO TIGHTEN THE CLIPS AND LOCK THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471813 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE

    Patients

    Seq Age Sex Outcome Treatment
    1