BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 9476094 · Received December 16, 2019

    Report

    Report Number
    3003898360-2019-01488
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    December 3, 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

    (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 WITH THE ROTATION TAB BENT. A CLOSED CLIP WAS PARTIALLY LOADED INCORRECTLY INTO THE JAWS. ANOTHER CLIP WAS STUCK IN THE BENT ROTATION TAB. THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. REFERENCE FILE: (B)(4) FOR INVESTIGATION PHOTOS. FIRST, THE PARTIALLY LOADED CLIP AND THE CLIP STUCK IN THE BENT ROTATION TAB WERE REMOVED. THE TRIGGER CYCLE WAS THEN COMPLETED AND IT WAS OBSERVED THAT THE NEXT CLIP WAS OUT OF POSITION IN THE CHANNEL. 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 THE FEEDER WAS TO THE SIDE OF THE CLIP. 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 12 CLIPS REMAINING INCLUDING THE PARTIALLY LOADED CLIPS, INDICATING THAT 3 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: (B)(4) 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 "CLIP NOT LOADING PROPERLY" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONE DEVICE WAS RETURNED WITH THE ROTATION TAB BENT. A CLOSED CLIP WAS PARTIALLY LOADED INCORRECTLY INTO THE JAWS. ANOTHER CLIP WAS STUCK IN THE BENT ROTATION TAB. UPON FUNCTIONAL INSPECTION, THE CLIP WAS UNABLE TO LOAD PROPERLY. 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 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 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
    1268886 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE

    Patients

    Seq Age Sex Outcome Treatment
    1