BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 8678817 · Received June 7, 2019

    Report

    Report Number
    3003898360-2019-00666
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 14, 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). PER DHR THE PRODUCT AUTO ENDO5 ML, LOT # 73G1600712 WAS MANUFACTURED ON 08/01/2016 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 08/02/2016. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER RETURNED ONE UNIT 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 WAS RETURNED WITH THE FIRST CLIP PROTRUDING FROM THE CHANNEL. 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 COULD BE HEARD INDICATING THAT THE INTERNAL RATCHET EARS ARE INTACT. THE FIRST CLIP WAS UNABLE TO LOAD PROPERLY AS ONE OF THE PIERCED BOSSES WAS SHEARED OFF. A BROKEN HOOK LOADED INTO THE JAWS AND FELL OUT. AT THIS TIME, IT WAS OBSERVED THAT THE NEXT CLIP WAS OUT OF POSITION IN THE CHANNEL. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. IT WAS FOUND THAT THE CLIPS WERE OUT OF POSITION AND STACKING ON ONE ANOTHER. THE SAMPLE WAS RECEIVED WITH 6 CLIPS REMAINING IN THE CHANNEL INDICATING THAT 9 CLIPS WERE FIRED BY THE END USER. THE CLIP STACKING WAS A RESULT OF THE MANUFACTURING PROCESS. A NONCONFORMANCE HAS ALREADY BEEN OPENED AS A RESULT OF THIS ISSUE. CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE TO IMPROVE THE DESIGN AND MANUFACTURING OF THE DEVICE AND TO HELP PREVENT THE CLIP STACKING ISSUE FROM RECURRING. THE RECEIVED SAMPLE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS BEING PUT IN PLACE. 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 CLIP STACKING WAS A RESULT OF THE MANUFACTURING PROCESS. A NONCONFORMANCE HAS ALREADY BEEN OPENED AS A RESULT OF THIS ISSUE. CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE TO IMPROVE THE DESIGN AND MANUFACTURING OF THE DEVICE AND TO HELP PREVENT THE CLIP STACKING ISSUE FROM RECURRING. THE RECEIVED SAMPLE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS BEING PUT IN PLACE. THE REPORTED COMPLAINT OF "CLIPS NOT CLOSING PROPERLY" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE SAMPLE WAS RETURNED WITH THE FIRST CLIP PROTRUDING FROM THE CHANNEL. UPON FUNCTIONAL INSPECTION, THE FIRST CLIP WAS UNABLE TO LOAD PROPERLY AS ONE OF THE PIERCED BOSSES WAS SHEARED OFF. A BROKEN HOOK LOADED INTO THE JAWS AND FELL OUT. AT THIS TIME, IT WAS OBSERVED THAT THE NEXT CLIP WAS OUT OF POSITION IN THE CHANNEL. IT WAS FOUND THAT THE CLIPS WERE OUT OF POSITION AND STACKING ON ONE ANOTHER. THE ROOT CAUSE OF THIS COMPLAINT ISSUE IS RELATED TO THE MANUFACTURING PROCESS. A NONCONFORMANCE HAS ALREADY BEEN OPENED AS A RESULT OF THIS ISSUE. CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE TO IMPROVE THE DESIGN AND MANUFACTURING OF THE DEVICE AND TO HELP PREVENT THE CLIP STACKING ISSUE FROM RECURRING. THE RECEIVED SAMPLE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS BEING PUT IN PLACE.

    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
    472027 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE

    Patients

    Seq Age Sex Outcome Treatment
    1