BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 9481996 · Received December 17, 2019

    Report

    Report Number
    3003898360-2019-01493
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 15, 2019
    Report Date
    December 2, 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 MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE WAS RETURNED WITH ITS TRIGGER PARTIALLY ENGAGED AND THE ROTATION TAB BENT. A CLIP WAS PARTIALLY LOADED INCORRECTLY AND WAS STUCK IN THE BENT ROTATION TAB. THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. REFERENCE FILE ANP1900073784 FOR INVESTIGATION PHOTOS. FIRST, THE PARTIALLY LOADED CLIP WAS MANUALLY REMOVED , AND THE TRIGGER CYCLE WAS COMPLETED. FUNCTIONAL INSPECTION WAS THEN 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 NEXT CLIP SHOT OUT OF THE CHANNEL AND OUT OF THE JAWS. NO CLIP WAS IN THE FOLLOWING POSITION OF THE CHANNEL. THE SAMPLE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. IT WAS FOUND THAT THE CLIPS WERE OUT OF POSITION AND STACKING ON ONE ANOTHER IN THE CHANNEL. THE SAMPLE WAS RECEIVED WITH 9 CLIPS REMAINING IN THE CHANNEL, INDICATING THAT 6 CLIPS WERE FIRED BY THE END USER. THE CLIP STACKING PREVENTED THE CLIPS FROM LOADING PROPERLY INTO THE JAWS. IT COULD NOT BE DETERMINED EXACTLY HOW OR WHEN THE CLIPS BECAME OUT OF POSITION. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. REFERENCE FILE ANP1900073784 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 CLIP STACKING PREVENTED THE CLIPS FROM LOADING PROPERLY INTO THE JAWS. IT COULD NOT BE DETERMINED EXACTLY HOW OR WHEN THE CLIPS BECAME OUT OF POSITION. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. THE REPORTED COMPLAINT OF "CLIPS NOT LOADING PROPERLY" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONE DEVICE WAS RETURNED WITH THE ROTATION TAB BENT. A CLIP WAS PARTIALLY LOADED INCORRECTLY AND WAS STUCK IN THE BENT ROTATION TAB. UPON FUNCTIONAL INSPECTION, THE NEXT CLIP WAS UNABLE TO LOAD PROPERLY INTO THE JAWS. THERE WAS NO CLIP IN THE FOLLOWING POSITION OF THE CHANNEL. THE SAMPLE WAS DISASSEMBLED , AND IT WAS FOUND THAT THE CLIPS WERE OUT OF POSITION AND STACKING ON ONE ANOTHER. THE CLIP STACKING PREVENTED THE CLIPS FROM LOADING PROPERLY INTO THE JAWS. ALTHOUGH THE REPORTED COMPLAINT ISSUE WAS CONFIRMED BASED ON FUNCTIONAL TESTING, IT COULD NOT BE DETERMINED EXACTLY HOW OR WHEN THE CLIPS BECAME OUT OF POSITION. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER TRIED TO LOAD A CLIP AT JAW, CLIP SHOULD BE OPENED BUT IT WAS LOCKED WHEN IT WAS LOADED AT THE JAW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML LOT# 73E1900153 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 A CLIP AT JAW, CLIP SHOULD BE OPENED BUT IT WAS LOCKED WHEN IT WAS LOADED AT THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277268 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE 73E1900153

    Patients

    Seq Age Sex Outcome Treatment
    1