BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL L 10MM ENDO APPLIER

    MDR report key: 4912044 · Received July 14, 2015

    Report

    Report Number
    1044475-2015-00195
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 16, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEF
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD (DHR) FOR THE INSTRUMENTS IN QUESTION, WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THE RETURNED INSTRUMENT WAS EVALUATED AND FOUND THAT THE JAWS ARE ALIGNED PROPERLY AND THAT THIS INSTRUMENT PICKS UP, RETAINS, CLOSES, AND RELEASES CLIPS BOTH WITH AND WITHOUT THE USE OF SILASTIC TEST TUBING , AS REQUIRED OF ITS FUNCTION AND NO CLIPS BROKE DURING TESTING. PARTS WERE 100% VISUALLY INSPECTED AND TESTED AT THE MANUFACTURING FACILITY BEFORE INSTRUMENTS WERE SENT TO CUSTOMER. NO IRREGULARITIES WERE FOUND AND OR REPORTED AT THE TIME OF INSPECTION AND ASSEMBLY OF THE PRODUCT, AS THIS IS A STANDARDIZED PROCESS FOR ALL INSTRUMENTS MANUFACTURED AT THIS FACILITY. WE ARE UNABLE TO VALIDATE THE ALLEGED COMPLAINT SINCE WE WERE UNABLE TO REPLICATE THE ALLEGED CONDITION. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: WHILE CLOSING THE CLIP ON A VESSEL DURING A LAPAROSCOPIC NEPHRECTOMY, THE CLIP BROKE. THE PHYSICIAN IS NOT SURE IF ALL PIECES OF THE BROKEN CLIP WERE RETRIEVED. THE PATIENT'S CURRENT CONDITION WAS LISTED AS CRITICAL. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ALLEGED EVENT: WHILE CLOSING THE CLIP ON A VESSEL DURING A LAPAROSCOPIC NEPHRECTOMY, THE CLIP BROKE. THE PHYSICIAN IS NOT SURE IF ALL PIECES OF THE BROKEN CLIP WERE RETRIEVED. THE PATIENT'S CURRENT CONDITION WAS LISTED AS CRITICAL. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457648 HOL L 10MM ENDO APPLIER APPLIER GEF TELEFLEX MEDICAL 06F1388091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention