BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPRO

    MDR report key: 4557539 · Received February 9, 2015

    Report

    Report Number
    4557539
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    November 12, 2014
    Report Date
    February 9, 2015
    Manufacturer
    LINVATEC CORPORATION D/B/A CONMED LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHEN SETTING UP THE OSCILLATING SAW FOR LEG AMPUTATION, THE SAW BEGAN RUNNING WHEN GAS SUPPLY WAS TURNED ON, EVEN THOUGH THE SAW WAS SET ON 'SAFE'. STAFF THEN SHUT OFF GAS SUPPLY, REMOVED THE SAW AND SENT FOR A NEW SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91886 POWERPRO SURGICAL SAW HWE LINVATEC CORPORATION D/B/A CONMED LINVATEC PRO6175 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *