BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 8679200 · Received June 7, 2019

    Report

    Report Number
    3003898360-2019-00673
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 15, 2019
    Manufacturer
    TELEFLEX MEDICAL
    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

    (B)(4). THE CUSTOMER RETURNED ONE UNIT 543965 AUTOENDO5 ML FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAG NIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE WAS RETURNED WITH ITS TRIGGER PARTIALLY ENGAGED AND WITH A BROKEN CLIP PROTRUDING SLIGHTLY FROM THE CHANNEL. THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. IT WAS OBSERVED THAT THE SAMPLE WAS MANUFACTURED IN JUNE 2015 BASED ON THE LOT NUMBER PROVIDED. THE SHELF LIFE OF THE DEVICE IS 3 YEARS AND THE USE-BY-DATE IS IDENTIFIED ON THE PACKAGING. BASED ON THE EVENT DATE REPORTED, IT APPEARS THAT THE DEVICE WAS USED BEYOND ITS SHELF LIFE. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT ISSUE IS USER ERROR AND IN-SERVICE CI-0000120 HAS BEEN REQUESTED. FIRST, THE BROKEN CLIP WAS MANUALLY REMOVED. FUNCTIONAL INSPECTION WAS THEN PERFORMED ON THE RETURNED SAMPLE BY ATTEMPTING TO ENGAGE THE TRIGGER USING HAND PRESSURE. HOWEVER, THE TRIGGER JAMMED WHICH PREVENTED THE TRIGGER CYCLE FROM BEING COMPLETED. IT WAS OBSERVED THAT THE TOP JAW WAS OUT OF POSITION AND THERE WAS NO CLIP IN THE NEXT POSITION OF THE CHANNEL. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. UPON DISASSEMBLY, IT WAS FOUND THAT THE YOKE PIN WAS LOOSE IN THE HANDLE AND WAS NOT CONNECTED TO THE YOKE. THE PROXIMAL END OF THE YOKE WAS BENT AND THERE WAS MATERIAL FROM THE YOKE STUCK IN THE FEEDER SPRING. THE CLIPS WERE ALSO OUT OF POSITION AND STACKING ON ONE ANOTHER. MULTIPLE DAMAGES WERE FOUND ON THE FEEDER. THE PUSHER HEAD AND THE TAB ON THE PROXIMAL END OF THE FEEDER WERE SEVERELY BENT. THE FEEDER TABS THROUGHOUT THE LENGTH OF THE FEEDER WERE ALSO BENT ABNORMALLY. A PIECE OF THE YOKE WAS ALSO STUCK ON THE TAB ON THE PROXIMAL END OF THE FEEDER. THE CENTERING TAB WAS BENT AT THE DISTAL END OF THE CHANNEL. THE TOP JAW WAS FOUND TO BE MANUFACTURED INCORRECTLY AS THE JAW FLAG WAS POINTING DOWN ON ONE SIDE AND FLAT ON THE OTHER SIDE. THE SAMPLE WAS RECEIVED WITH 10 CLIPS REMAINING, INCLUDING THE PARTIALLY LOADED BROKEN CLIP INDICATING THAT 5 CLIPS WERE FIRED BY THE END USER. R & D WAS CONSULTED AND THE BENT CENTERING TAB PREVENTED THE CLIPS FROM LOADING PROPERLY. IF THE CLIP IS NOT MANUALLY CLEARED PRIOR TO LOADING ANOTHER CLIP, THE CLIPS CAN BE HELD UP IN THE LOADING SEQUENCE AND STACK ON ONE ANOTHER IN THE CHANNEL. THE CLIP STACK CAUSED THE FEEDER SPRING TO BIND UP INTERNALLY IN THE YOKE AND RESULTED IN THE OBSERVED DAMAGES TO THE FEEDER AND THE YOKE. IT COULD NOT BE DETERMINED EXACTLY HOW OR WHAT CAUSED THE CENTERING TAB TO BEND. THE JAW FLAG BEING OUT OF SPECIFICATION IS A SUPPLIER RELATED ISSUE. THE JAWS ARE A PURCHASED COMPONENT FROM A SUPPLIER. NC 70017826 WAS PREVIOUSLY OPENED TO INVESTIGATE THIS ISSUE. CHANGES WERE ALSO IMPLEMENTED TO IMPROVE THE DESIGN AND MANUFACTURING OF THE DEVICE (I.E. D019908, D018662) TO PREVENT LOADING ISSUES ASSOCIATED WITH THE DEVICE FROM RECURRING. THE RECEIVED SAMPLE WAS MANUFACTURED PRIOR TO DESIGN AND MANUFACTURING CHANGES. HOWEVER, SINCE THE DEVICE WAS USED BEYOND ITS SHELF LIFE, THE ROOT CAUSE OF THIS COMPLAINT ISSUE IS USER ERROR AND IN-SERVICE CI-0000120 HAS BEEN REQUESTED. 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." SINCE THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE 'USER ERROR', IN-SERVICE CI-0000120 HAS BEEN REQUESTED. THE REPORTED COMPLAINT OF "CLIPS NOT CLOSING PROPERLY" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. MULTIPLE DEFECTS WERE OBSERVED ON THE DEVICE. HOWEVER, IT WAS ALSO OBSERVED THAT THE DEVICE WAS USED BEYOND ITS 3 YEAR SHELF LIFE BASED ON THE LOT NUMBER OF THE SAMPLE AND THE EVENT DATE REPORTED (18APR2019). THE DHR REVIEW CONFIRMED THAT THE SAMPLE WAS MANUFACTURED IN JUNE 2015. THE USE-BY-DATE IS IDENTIFIED ON THE PACKAGING. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT ISSUE IS USER ERROR AND IN-SERVICE CI-0000120 HAS BEEN REQUESTED.

    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 INVESTIGATION IS PENDING. THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML LOT #73F1500557 INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. 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
    472055 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL 73F1500557

    Patients

    Seq Age Sex Outcome Treatment
    1