BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL L ENDO APPLIER 10MM, 45CM

    MDR report key: 4791394 · Received May 21, 2015

    Report

    Report Number
    3010041511-2015-00001
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEF
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SURGERY WAS A ROBOTIC PROSTATECTOMY. THE DEVICE HISTORY REVIEW FOR THE HOL L 10MM ENDO APPLIER, 45CM, WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. EVALUATION AND FUNCTION CHECKING OF THE RETURNED INSTRUMENT SHOWED THAT THE JAWS OF THE INSTRUMENT ARE ALIGNED PROPERLY AND THE INSTRUMENT PICKS-UP, RETAINS, CLOSES AND RELEASES MULTIPLE CLIPS OVER TEST TUBING AS REQUIRED OF ITS FUNCTION. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE ALLEGED ISSUE. PARTS WERE 100% VISUALLY INSPECTED AND TESTED BY THE MANUFACTURER BEFORE RELEASE AND NO IRREGULARITIES WERE FOUND OR REPORTED AT THE TIME OF INSPECTION OR ASSEMBLY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME HOWEVER, THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    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: IT WAS REPORTED THAT THE CLIPS DO NOT PINCH AND THERE IS A STRANGE (ZINK) COATING ON INSTRUMENT. ROBOTIC SURGERY FOR PROSTATECTOMY WAS PERFORMED THE CLIPS NEVER LOCKED WHEN TISSUE WAS FOUND BETWEEN THE JAWS. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331242 HOL L ENDO APPLIER 10MM, 45CM APPLIER GEF TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1