BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STABLILZER ARM HERCULES

    MDR report key: 3172435 · Received June 5, 2013

    Report

    Report Number
    2953686-2013-00005
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 4, 2013
    Manufacturer
    ENDOSCOPIC TECHNOLOGIES
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS PURCHASED FROM THE MFR IN (B)(6) 2010. THE INSTRUCTIONS FOR USE AND DEVICE LABELING REQUIRE THAT THE CABLE INTEGRITY AND FUNCTIONALITY BE INSPECTED PRIOR TO EACH USE. THE INSTRUCTIONS INDICATED THERE SHOULD BE NO SIGNS OF WEAR OR FRAYED CABLE PRESENT. THE INITIAL REPORT INDICATED THAT THE CABLE WAS FRAYED AND SO THE DEVICE SHOULD NOT HAVE BEEN USED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, WE RECEIVED THE FOLLOWING REPORT FROM THE DISTRIBUTOR: THE WIRE IS ONLY A LITTLE FRAYED BUT CAME UNATTACHED TO THE BASE OF THE HERCULES. ALL THE BEADS OF THE ARM FELL IN THE PT. THE PIECES WERE VISUALLY LOCATED AND PULLED FROM THE PT. THE PT UNDERWENT A SERIES OF X-RAYS TO CHECK FOR ANY PIECES LEFT IN THE BODY. X-RAYS SHOWED EVERYTHING WAS REMOVED. USED AN ADDITIONAL HERCULES ARM TO COMPLETE THE CASE. THE PT EXPERIENCED NO BLOOD LOSS DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249352 UNIVERSAL STABLILZER ARM HERCULES HERCULES DWS ENDOSCOPIC TECHNOLOGIES 401-152 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention