BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKING ELEMENT, S-LINE, BIPOLAR

    MDR report key: 3365184 · Received September 20, 2013

    Report

    Report Number
    1418479-2013-00024
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 21, 2013
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, 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. DEVICE WAS MISSING HINGE AND NUT. SPARK MAY HAVE BEEN DUE TO MOISTURE FOUND IN BLOCK DUE TO LACK OF CLEANING. ROOT CAUSE IS HANDLING AND REPROCESSING. DEVICE HISTORY: MANUFACTURED 05/01/2010, PURCHASE (B)(6) 2012, REPAIRED (B)(4) 2012. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADD'L INFO, WE WILL PROVIDE FDA WITH F/U INFO.

    Description of Event or Problem · 1

    SALES REP 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
    475042 WORKING ELEMENT, S-LINE, BIPOLAR WORKING ELEMENT FDC RICHARD WOLF GMBH 8680.224 65Y10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other