BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 7374177 · Received March 27, 2018

    Report

    Report Number
    3003898360-2018-00178
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 13, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K133202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 WAS RETURNED WITH ITS TRIGGER PARTIALLY ENGAGED AND THE JAWS PARTIALLY CLOSED. THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. REFERENCE FILE PIC_ANP19000 59153 FOR INVESTIGATION PHOTOS. DIMENSIONAL INSPECTION WAS PERFORMED TO MEASURE THE HEIGHT FROM THE TIP OF THE BOTTOM JAW TO THE CENTER OF THE BOSS ON THE JAW. THE SPECIFICATION AS OUTLINED IN PART DRAWING G00455 IS .098" +/- .0055". IT WAS FOUND THAT THE RETURNED JAW WAS .08496" WHICH DOES NOT MEET THE SPECIFICATION. THIS CONFIRMS THAT THE JAW WAS BENT, NOT THAT IT WAS OUT OF SPECIFICATION. THIS SAMPLE WAS REVIEWED WITH A R & D ENGINEER. FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE BY ATTEMPTING TO ENGAGE THE TRIGGER USING HAND PRESSURE. UPON ENGAGEMENT OF THE TRIGGER, THE 1ST CLIP WAS UNABLE TO LOCK SINCE THE JAWS DID NOT CLOSE ALL THE WAY. ANOTHER ATTEMPT WAS MADE AND THE JAWS WERE ONCE AGAIN UNABLE TO CLOSE ALL THE WAY. HOWEVER, THE CLIP WAS ABLE TO LOCK THIS TIME. THE OTHER REMARKS: SAMPLE WAS RECEIVED WITH 2 CLIPS REMAINING IN THE CHANNEL INDICATING THAT 13 CLIPS WERE FIRED BY THE END USER. THE DEVICE WAS DISASSEMBLED IN ORDER TO INSPECT THE INTERNAL COMPONENTS. UPON DISASSEMBLY, IT WAS OBSERVED THAT THE TIP OF THE BOTTOM JAW APPEARS TO HAVE BEEN BENT AND THE DISTAL END OF THE OUTER TUBE APPEARS TO HAVE BEEN DAMAGED. IT APPEARS THAT THE DAMAGES RESULTED FROM CLOSING A CLIP OVER SOMETHING HARD. THE OBSERVED DAMAGES PREVENTED THE CLIPS FROM CLOSING SINCE THE JAWS WERE UNABLE TO CLOSE ALL THE WAY. THE BOTTOM JAW WAS MEASURED AND IT WAS CONFIRMED TO HAVE BEEN BENT TO THE POINT WHERE IT DID NOT FALL WITHIN THE SPECIFICATION. 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 PART DRAWING FOR THE BOTTOM JAW, G00455, WAS ALSO REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE CONDITION OF THE SAMPLE RECEIVED INDICATES THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED COMPLAINT OF "THE APPLIER DOES NOT LOCK CLIPS" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. UPON FUNCTIONAL INSPECTION, THE JAWS WERE UNABLE TO CLOSE COMPLETELY WHEN THE CLIPS WERE FIRED. IT WAS FOUND THAT THE TIP OF THE BOTTOM JAW APPEARS TO HAVE BEEN BENT AND THE DISTAL END OF THE OUTER TUBE APPEARS TO HAVE BEEN DAMAGED. DIMENSIONAL INSPECTION WAS PERFORMED TO MEASURE THE HEIGHT FROM THE TIP OF THE BOTTOM JAW TO THE CENTER OF THE BOSS ON THE JAW. THE SPECIFICATION AS OUTLINED IN PART DRAWING G00455 IS .098" +/- .0055". IT WAS FOUND THAT THE RETURNED JAW WAS .08496" WHICH DOES NOT MEET THE SPECIFICATION. THIS CONFIRMS THAT THE JAW WAS BENT, NOT THAT IT WAS OUT OF SPECIFICATION. IT APPEARS THAT THE DAMAGES RESULTED FROM CLOSING A CLIP OVER SOMETHING HARD. WHEN THE DEVICE WAS CLOSED OVER SOMETHING HARD, THE BOTTOM JAW GOT BENT TO THE POINT WHERE IT DID NOT FALL WITHIN THE SPECIFICATION. THE OBSERVED DAMAGES PREVENTED THE CLIPS FROM CLOSING SINCE THE JAWS WERE UNABLE TO CLOSE ALL THE WAY. AT THE TIME OF MANUFACTURING ASSEMBLY, THE AUTOENDO5 IS 100% INSPECTED FOR PROPER CLIP LOADING AND CLOSURE. IT IS UNLIKELY THAT THESE TYPES OF DAMAGES WERE PRESENT AT THE TIME OF MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED DEFECT. BASED UPON THE OBSERVED DAMAGE, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED COMPLAINT OF "THE APPLIER DOES NOT LOCK CLIPS" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. UPON FUNCTIONAL INSPECTION, THE JAWS WERE UNABLE TO CLOSE COMPLETELY WHEN THE CLIPS WERE FIRED. IT WAS FOUND THAT THE TIP OF THE BOTTOM JAW APPEARS TO HAVE BEEN BENT AND THE DISTAL END OF THE OUTER TUBE APPEARS TO HAVE BEEN DAMAGED. DIMENSIONAL INSPECTION WAS PERFORMED TO MEASURE THE HEIGHT FROM THE TIP OF THE BOTTOM JAW TO THE CENTER OF THE BOSS ON THE JAW. THE SPECIFICATION AS OUTLINED IN PART DRAWING G00455 IS .098" +/- .0055". IT WAS FOUND THAT THE RETURNED JAW WAS .08496" WHICH DOES NOT MEET THE SPECIFICATION. THIS CONFIRMS THAT THE JAW WAS BENT, NOT THAT IT WAS OUT OF SPECIFICATION. IT APPEARS THAT THE DAMAGES RESULTED FROM CLOSING A CLIP OVER SOMETHING HARD. WHEN THE DEVICE WAS CLOSED OVER SOMETHING HARD, THE BOTTOM JAW GOT BENT TO THE POINT WHERE IT DID NOT FALL WITHIN THE SPECIFICATION. THE OBSERVED DAMAGES PREVENTED THE CLIPS FROM CLOSING SINCE THE JAWS WERE UNABLE TO CLOSE ALL THE WAY. AT THE TIME OF MANUFACTURING ASSEMBLY, THE AUTOENDO5 IS 100% INSPECTED FOR PROPER CLIP LOADING AND CLOSURE. IT IS UNLIKELY THAT THESE TYPES OF DAMAGES WERE PRESENT AT THE TIME OF MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED DEFECT. BASED UPON THE OBSERVED DAMAGE, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE APPLIER THE DEVICE DOES NOT LOCK THE CLIPS. SO ANOTHER APPLIER HAS TO BE USED. THERE WERE NO CONSEQUENCE FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML LOT # 73M1700115 INVESTIGATIONS 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 WHILE USING THE APPLIER THE DEVICE DOES NOT LOCK THE CLIPS. SO ANOTHER APPLIER HAS TO BE USED. THERE WERE NO CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218969 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL 73M1700115

    Patients

    Seq Age Sex Outcome Treatment
    1