BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL HAND THERMASEAL

    MDR report key: 1082186 · Received July 25, 2008

    Report

    Report Number
    2954339-2008-00003
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 21, 2008
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    GEI
    PMA / PMN Number
    062257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS ALSO FOUND THAT THE FIXTURE REVISION USED TO MANUFACTURE THE DEVICE WAS THE ROOT CAUSE OF THE RIVET APPLICATION ERROR. THIS WAS CORRECTED. ALL PRODUCT MANUFACTURED WITH THIS FIXTURE REVISION WAS WITHDRAWN.

    Description of Event or Problem · 1

    THIS IS A PROACTIVE REPORT, NO ADVERSE EVENTS OCCURRED. A DEVICE DISPLAYED NO ARTICULATION UPON INITIAL USE OF THE DEVICE DUE TO A RIVET APPLICATION ERROR. IT WAS REPORTED BY A SALES REPRESENTATIVE, THE OPERATING ROOM STAFF WAS NOT OBSERVED USING THE IFU OR PERFORMING A DEVICE PRE-TEST AS IS INDICATED IN THE IFU. IF THIS HAD BEEN PERFORMED, THE PROBLEM WOULD HAVE BEEN IDENTIFIED PRIOR TO USE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAL HAND THERMASEAL REAL HAND THERMASEAL GEI STARION INSTRUMENTS N-10700 804019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK