BEUDAMED
    FDA Adverse Event Other Summary report: N

    1222081-2008-00006

    MDR report key: 1032559 · Received March 21, 2008

    Report

    Report Number
    1222081-2008-00006
    Event Type
    Other
    Date Received
    March 21, 2008
    Product Code
    HTT
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT INSTRUMENT WAS EVALUATED BY MFR AND BURR SHAFT WAS FOUND TO BE BENT (.03619" OUT OF SPEC) AND SIGNIFICANT SCORING AND RAGGEDNESS OF THE DISTAL HEAT SHRINK WAS NOTED. THE OUTER TUBE WAS ALSO BENT (.05068"). THIS IS EVIDENE OF POSSIBLE EXCESSIVE SIDE LOAD PRESSURE CAUSING INNER TUBE TO COME IN CONTACT WITH THE OUTER. THIS FRICTION CAN PRODUCE HEAT. REPORT ALSO STATED THAT THERE MAY HAVE BEEN AN INTERRUPTION OF SALINE FLOW THAT COOLS BURR DURING OPERATION WHICH MAY HAVE CONTRIBUTED TO BURR OVERHEATING. SAMPLES WERE TAKEN OUT OF THE SAME LOT# BOX SUBJECT BURR CAME FROM; THEY WERE FOUND TO BE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTT

    Patients

    Seq Age Sex Outcome Treatment
    1