BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 FX45 2N 48" BARD

    MDR report key: 6912330 · Received October 3, 2017

    Report

    Report Number
    3004365956-2017-00361
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 18, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE UNIT 543965 AUTOENDO5 ML FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. REFERENCE ATTACHED FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE BY ATTEMPTING TO ENGAGE THE TRIGGER USING HAND PRESSURE. UPON ENGAGEMENT OF THE TRIGGER, NO RATCHET SOUND COULD BE HEARD INDICATING THAT THE INTERNAL RATCHET EARS ARE BROKEN. NO CLIP FIRED. THE TRIGGER WAS ENGAGED SEVERAL MORE TIMES WITH NO CLIPS FIRING. THE SAMPLE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. UPON DISASSEMBLY, NO FURTHER DAMAGES WERE FOUND. THE SAMPLE WAS RECEIVED WITH 0 CLIPS REMAINING IN THE CHANNEL INDICATING THAT ALL 15 CLIPS WERE FIRED BY THE END USER. THE IFU FOR THIS PRODUCT, L03496, 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." OTHER REMARKS: 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. ALTHOUGH NO CLIPS WERE RETURNED, THE BROKEN RATCHET EARS COULD LEAD TO LOADING ISSUES. THE REPORTED COMPLAINT OF "HANDLE STOPS" WAS NOT CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONE DEVICE WAS RETURNED. THE DEVICE WAS RETURNED WITH 0 CLIPS REMAINING. UPON FUNCTIONAL INSPECTION, IT WAS FOUND THAT THE INTERNAL RATCHET EARS WERE BROKEN. HOWEVER, THE HANDLE WAS ABLE TO COMPLETE ITS CYCLE AND NEVER GOT STUCK. THE DAMAGE TO THE RATCHET EARS COULD AFFECT THE END USER'S ABILITY TO PROPERLY LOAD AND APPLY CLIPS AND COULD CAUSE THE HANDLE TO GET STUCK. AT THE TIME OF MANUFACTURING ASSEMBLY, THE AUTOENDO5 IS 100% INSPECTED FOR PROPER CLIP LOADING AND CLOSURE. IT IS UNLIKELY THAT THIS TYPE OF DAMAGE WAS PRESENT AT THE TIME OF MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE AUTOENDO5 WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. ALTHOUGH THE REPORTED COMPLAINT ISSUE COULD NOT BE CONFIRMED SINCE THE HANDLE WAS ABLE TO COMPLETE ITS CYCLE AND NEVER GOT STUCK, THE BROKEN INTERNAL RATCHET EARS AND THE BENT TUBE COULD CAUSE ISSUES WITH THE LOADING OF THE CLIPS AND COULD CAUSE THE HANDLE TO GET STUCK. THEREFORE, BASED UPON THE OBSERVED DAMAGE, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SACRO-SPINAL FIXATION WHEN THE SURGEON FIRED THE FIXT THE BULLET BROKE OFF THE SUTURE. THE BULLET WAS IN THE PATIENT AND THE DOCTOR HAD ONLY THE SUTURE IN HIS HANDS. THEY HAD FOUND THE BULLET WITH X-RAY AND IT WAS POSSIBLE TO REMOVE THE BULLET. THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SACRO-SPINAL FIXATION WHEN THE SURGEON FIRED THE FIXT THE BULLET BROKE OFF THE SUTURE. THE BULLET WAS IN THE PATIENT AND THE DOCTOR HAD ONLY THE SUTURE IN HIS HANDS. THEY HAD FOUND THE BULLET WITH X-RAY AND IT WAS POSSIBLE TO REMOVE THE BULLET. THE PATIENT'S CONDITION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689306 DEK BL MF 0 FX45 2N 48" BARD GAB TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention