BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED TOOL LEGACY, B-5

    MDR report key: 1023504 · Received April 2, 2008

    Report

    Report Number
    1625507-2008-00017
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Report Date
    March 4, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISSECTING TOOL HAS NOT BEEN RETURNED FOR EVALUATION. DISSECTING TOOL BREAKAGE IS A KNOWN PROBLEM THAT MAY OCCUR DURING USE OF HIGH SPEED DISSECTING TOOLS. EXCESSIVE CUTTING FORCE OR BENDING OF TOOLS DURING USE CAN CAUSE BREAKAGE. WARNING IS PROVIDED IN DEVICE USER MANUAL INDICATING "DO NOT USE EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, ON ATTACHMENTS OR DISSECTING TOOLS. THIS MAY CAUSE TOOL TO BEND OR BREAK AND CAUSE INJURY TO PT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISSECTING TOOL BROKE DURING A CASE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED TOOL LEGACY, B-5 PNEUMATIC SURG DRILL TOOL LEGACY HBB MEDTRONIC POWERED SURGICAL SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1