BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPOWER TWO TRIGGER MODULAR HANDPIECE

    MDR report key: 1001069 · Received February 14, 2008

    Report

    Report Number
    1017294-2008-00107
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Report Date
    January 16, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    FCO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS HANDPIECE FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. DURING TESTING, THE EVALUATOR FOUND THIS DEVICE HAS THE POTENTIAL TO OPERATE IN THE SAFE MODE WHEN THE TRIGGER IS DEPRESSED, RELATED TO CONTROLLER FAILURE. A DESIGN CHANGE TO THE CONTROLLER HAS BEEN IMPLEMENTED FOR THIS FAILURE. THERE ARE NO SERIOUS INJURIES RELATED TO THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.

    Description of Event or Problem · 1

    THE CUSTOMER NOTED DURING PRE-OPERATIVE TESTING, THAT THE DEVICE TRIGGER WOULD LOCK UP, AND THE HANDPIECE WOULD RUN IN THE SAFE MODE. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPOWER TWO TRIGGER MODULAR HANDPIECE BATTERY HANDPIECE FCO CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA