BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 9476165 · Received December 16, 2019

    Report

    Report Number
    3003898360-2019-01490
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 28, 2019
    Report Date
    December 5, 2019
    Manufacturer
    TELEFLEX MEDICAL/MORRISVILLE
    Product Code
    FZP
    PMA / PMN Number
    K152081
    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 AE05ML AUTOEND05 ML FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAG NIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. REFERENCE FILE ANP1900073973 FOR INVESTIGATION PHOTOS. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE BY ATTEMPTING TO ENGAGE THE TRIGGER USING HAND PRESSURE. UPON ENGAGEMENT OF THE TRIGGER, NO AUDIBLE RATCHET SOUND COULD BE HEARD INDICATING THAT THE INTERNAL RATCHET EARS ARE BROKEN. THE FIRST CLIP WAS ABLE TO LOAD PROPERLY INTO THE JAWS AND WAS SUCCESSFULLY APPLIED TO OVER-STRESSED SURGICAL TUBING. THIS WAS REPEATED WITH THE SAME RESULT FOR THE NEXT 5 CLIPS. HOWEVER, ON THE 7TH ATTEMPT, THE CLIP WAS UNABLE TO LOAD PROPERLY. THE INDICATOR CLIP WAS IN THE NEXT POSITION OF THE CHANNEL, INDICATING THAT NO CLIPS WERE REMAINING. THE INDICATOR CLIP WAS FIRED AND THE SAMPLE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. NO FURTHER DAMAGES WERE OBSERVED. THE SAMPLE WAS RECEIVED WITH 7 CLIPS REMAINING IN THE CHANNEL INDICATING THAT 8 CLIPS WERE FIRED BY THE END USER. THE BROKEN RATCHET PREVENTED THE CLIP FROM PROPERLY LOADING INTO THE JAWS. IT COULD NOT BE DETERMINED WHAT EXACTLY CAUSED THE RATCHET EARS TO BREAK. A CAPA HAS BEEN PREVIOUSLY OPENED TO FURTHER INVESTIGATE LOADING AND FEEDING ISSUES. REFERENCE FILE ANP1900073973 FOR INVESTIGATION PHOTOS. THE IFU FOR THIS PRODUCT, L06072, 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 BROKEN RATCHET PREVENTED THE CLIP FROM LOADING PROPERLY. IT COULD NOT BE DETERMINED WHAT EXACTLY CAUSED THE RATCHET EARS TO BREAK BUT A CAPA HAS BEEN PREVIOUSLY OPENED TO FURTHER INVESTIGATE LOADING AND FEEDING ISSUES. THE REPORTED COMPLAINT OF "CLIP NOT LOADING PROPERLY" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. UPON FUNCTIONAL INSPECTION, NO AUDIBLE RATCHET SOUND WAS HEARD INDICATING THAT THE INTERNAL RATCHET EARS WERE BROKEN. ONE OF THE CLIPS WAS UNABLE TO LOAD PROPERLY. THE BROKEN RATCHET PREVENTED THE CLIP FROM PROPERLY LOADING INTO THE JAWS. ALTHOUGH THE REPORTED COMPLAINT WAS CONFIRMED BASED ON FUNCTIONAL TESTING, IT COULD NOT BE DETERMINED WHAT EXACTLY CAUSED THE RATCHET EARS TO BREAK. A CAPA HAS BEEN PREVIOUSLY OPENED TO FURTHER INVESTIGATE LOADING AND FEEDING ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER TRIED TO LOAD CLIP AT JAW WHEN THE APPLIER WOULD NOT LOAD THE CLIP CORRECTLY IN THE JAW. SO FULL APERTURE WAS NOT ACHIEVED AS PART OF THE CLIP DID NOT LOAD INTO THE JAWS OF THE APPLIER APPROPRIATELY, HENCE CLIP FELL OUT THE APPLIER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML LOT# 73F180073 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER TRIED TO LOAD CLIP AT JAW WHEN THE APPLIER WOULD NOT LOAD THE CLIP CORRECTLY IN THE JAW. SO FULL APERTURE WAS NOT ACHIEVED AS PART OF THE CLIP DID NOT LOAD INTO THE JAWS OF THE APPLIER APPROPRIATELY, HENCE CLIP FELL OUT THE APPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270993 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE 73F1800731

    Patients

    Seq Age Sex Outcome Treatment
    1