BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKING ELEMENT

    MDR report key: 3912378 · Received June 27, 2014

    Report

    Report Number
    1418479-2014-00032
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 10, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FDC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED ON (B)(4) 2014. A FEW PARTS ON DEVICE WERE REPLACED DUE TO BEING LOOSE AND/OR WORN OUT. NO RECORD OF ANY ROUTINE MAINTENANCE OR REPAIRS. IF MOISTURE OR LIQUID WERE TO GET IN LOCK HOSING, A SPARK MAY OCCUR. (I.E. DEVICE NOT COMPLETELY DRIED AFTER REPROCESSING OR FROM FLUIDS DURING USE DUE TO WORN O-RING). 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 ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2014, FACILITY CONTACTED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) INCIDATING THEY WOULD LIKE TO SEND IN THEIR WORKING ELEMENT TO BE CHECKED, ROUTINE MAINTENANCE. ONE FACILITY RECEIVED COST ESTIMATE OF REPAIRS, FACILITY MENTIONED AN INCIDENT WHERE A SPARK OCCURRED. A FEW PARTS ON DEVICE WERE REPLACED DUE TO BEING LOOSE AND/OR WORK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376355 WORKING ELEMENT WORKING ELEMENT FDC RICHARD WOLF GMBH 8653.224 1106343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other