BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKING ELEMENT, S-LINE, BIPOLAR

    MDR report key: 3533978 · Received December 17, 2013

    Report

    Report Number
    1418479-2013-00035
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 18, 2013
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON (B)(4) 2013. SPARK MAY HAVE BEEN DUE TO MOISTURE FOUND IN BLOCK DUE TO LACK OF CLEANING. ROOT CAUSE IS WEAR AND TEAR. DEVICE HISTORY: MANUFACTURED 06/2009, NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDED FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) THAT DURING A PROCEDURE THE DEVICE SPARKED. NO INJURY TO PT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658734 WORKING ELEMENT, S-LINE, BIPOLAR WORKING ELEMENT FDC RICHARD WOLF GMBH 8680.224 65J09

    Patients

    Seq Age Sex Outcome Treatment
    1