BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 8678923 · Received June 7, 2019

    Report

    Report Number
    3003898360-2019-00664
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    January 11, 2019
    Report Date
    May 16, 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 AS IT WAS STUCK IN THE BENT ROTATION TAB. FIRST, THE PARTIALLY LOADED CLIP WAS MANUALLY REMOVED , AND THE TRIGGER CYCLE WAS COMPLETED. IT WAS OBSERVED THAT THE NEXT CLIP WAS OUT OF POSITION IN THE CHANNEL. 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 WAS UNABLE TO LOAD PROPERLY INTO THE JAWS OF THE APPLIER. THE SAMPLE 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 INCLUDING THE PARTIALLY LOADED CLIP, INDICATING THAT 9 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 CAME OUT OF POSITION. A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. 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 CAME OUT OF POSITION. A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THE CLIP STACKING ISSUE. THE REPORTED COMPLAINT OF "CLIP FELL FROM APPLIER" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONE SAMPLE WAS RETURNED WITH THE ROTATION TAB BENT AND A CLIP STUCK IN THE BENT ROTATION TAB. UPON FUNCTIONAL INSPECTION, THE NEXT CLIP WAS UNABLE TO LOAD PROPERLY INTO THE JAWS OF THE APPLIER. THE SAMPLE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. 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. IT COULD NOT BE DETERMINED EXACTLY HOW OR WHEN THE CLIPS CAME OUT OF POSITION. A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS PERFORMING A CHOLECYSTECTOMY. DURING PRETEST THE CLIP FELL FROM THE APPLIER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML LOT #73E1800201 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 THE USER WAS PERFORMING A CHOLECYSTECTOMY. DURING PRETEST THE CLIP FELL FROM THE APPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474221 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE 73E1800201

    Patients

    Seq Age Sex Outcome Treatment
    1