BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND DISSECTING TOOL

    MDR report key: 3150591 · Received June 6, 2013

    Report

    Report Number
    1625507-2013-00030
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT INCONCLUSIVE. NO EVALUATION COULD BE PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THIS IS A KNOWN FAILURE MODE THAT COULD OCCUR DUE TO EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, ON DISSECTING TOOLS. THE USER MANUAL CONTAINS THE FOLLOWING WARNING ¿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 PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF.¿ WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISSECTING TOOL BROKE DURING CRANIOTOMY PROCEDURE WHILE TURNING FLAP. THE BROKEN PIECE WAS REMOVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TOOL. THERE WAS NO PATIENT IMPACT AND NO SIGNIFICANT DELAY. THE TOOL IS HELD BY HOSPITAL QI, BUT MAY BE AVAILABLE FOR RETURN AT A LATER DATE. NURSE WILL NOTIFY ASM WHEN TOOL AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251703 LEGEND DISSECTING TOOL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS N/A 0006656385

    Patients

    Seq Age Sex Outcome Treatment
    1