BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKING ELEMENT ACTIVE BIPO 0/12/30

    MDR report key: 8363751 · Received February 22, 2019

    Report

    Report Number
    9611102-2018-00018
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    October 8, 2018
    Report Date
    October 16, 2018
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FDC
    UDI-DI
    04055207042939
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RWMIC SUBMITTING REPORT ON BEHALF OF RW (B)(4) (MANUFACTURER). AS DIFFERENT PRODUCTS WERE USED, THE INSTRUCTIONS FOR USE OF THE PRODUCTS USED IN COMBINATION WERE REVIEWED. THE BURNING WAS MOST LIKELY CAUSED BY LEAKAGE CURRENT FLOWING THROUGH THE PATIENT'S BODY IN SMALL QUANTITIES DURING EACH RF APPLICATION. IF THE PATIENT'S BODY IS TOUCHED BY A SMALL AREA DURING HF ACTIVATION, E.G. WITH THE FINGERTIP, THE HIGH CURRENT DENSITY MAY CAUSE COMBUSTION. IN ORDER TO LARGELY AVOID THE WELL-KNOWN PHENOMENON OF BURNING BY LEAKAGE CURRENT, IT IS RECOMMENDED TO KEEP THE EFFECT OF THE HF CURRENT AS LOW AS POSSIBLE AND TO AVOID SKIN-TO-SKIN CONTACT DURING ACTIVATION. DEVICE LABELING WAS REVIEWED FOR PATIENT CODE AND DEVICE CODES, SEE BELOW: CAUTION! IRRIGATION FLUID CAN BE ELECTRICALLY CONDUCTIVE! DEPENDING ON THE APPLICATION THE USER MUST SELECT A SUITABLE IRRIGATION FLUID. CAUTION! DANGER OF ELEVATED TEMPERATURES WHEN WORKING WITHOUT IRRIGATION FLUID! INJURIES TO THE MUCOUS MEMBRANE DUE TO EXCESSIVE TEMPERATURES ENDANGER THE PATIENT. ACTIVATE THE ELECTRODE ONLY WHILE IT IS IMMERSED IN IRRIGATION FLUID AND UNDER CONTINUOUS IRRIGATION. (B)(4) CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    ON NOVEMBER 07, 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A REPORT FROM RICHARD WOLF (B)(4) INVOLVING THE FOLLOWING DEVICES: 815.052 LOT 523/573 (MDR 9611102-2018-00015), 815.032 LOT 006/086 (MDR 9611102-2018-00016), 8674.205 LOT 1259038 (MDR 9611102-2018-00017), 8680.205 LOT 1255367 (THIS MDR), 8654.204 LOT 1202777 (MDR 9611102-2018-00019). IT WAS REPORTED THAT THE PATIENT SUFFERED THIRD DEGREE BURN ON THE RIGHT FINGER DUE TO HF APPLICATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSPECTION SHOWED THAT THE CAUSE OF THE FAULT DESCRIBED BY THE USER CANNOT BE TRACED BACK TO THE WORKING ELEMENTS OR HF CONNECTION CABLE MONO. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. NO DEFECTS WERE FOUND IN THE MEDICAL DEVICES. IN CONCLUSION, THE COMBUSTION WAS NOT CAUSED BY A FAULTY HF DEVICE OR ACCESSORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157307 WORKING ELEMENT ACTIVE BIPO 0/12/30 WORKING ELEMENT ACTIVE BIPO 0/12/30 FDC RICHARD WOLF GMBH 8680.205 1255367 04055207042939

    Patients

    Seq Age Sex Outcome Treatment
    1 Other