BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR WORKING ELEMENT

    MDR report key: 2151512 · Received June 23, 2011

    Report

    Report Number
    1418479-2011-00014
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF TWO OTHER WORKING ELEMENTS THAT WERE RETURNED FOR REPAIR WITH THE PROBLEM WORKING ELEMENT, SHOWED NON-WOLF COMPONENT USED. THIS WAS AN INDICATION THAT A THIRD PARTY REPAIR WAS USED BY THE FACILITY. EVAL SUMMARY: VISUAL INSPECTION OF THE DEVICE CONFIRMED BLACK PLASTIC MATERIAL MELTED ON THE WHITE BLOCK HOUSING. THIS IS THE LOCATION WHERE THE SPARK OCCURRED. A BLACK SCREW WAS REPLACED AND ALSO A BLACK PUSH BUTTON WAS REPLACED. THE BLACK BRACKET WAS REPLACED DUE TO BEING BENT FORWARD. ONE THUMB RING WAS HEAVILY DAMAGED AND BRASS MATERIAL WAS VISIBLY SEEN. TWO OTHER WORKING ELEMENTS NOT ASSOCIATED WITH THIS PARTICULAR ONE WERE RETURNED FOR REPAIR. THERE WAS CLEAR EVIDENCE OF A NON-WOLF COMPONENT USED IN A PRIOR REPAIR. THE BLACK BRACKETS ON BOTH WORKING ELEMENTS WERE DAMAGED TO THE POINT THAT YOU VISIBLY COULD SEE THE BRASS MATERIAL. THE BLACK BRACKETS WERE ALSO BENT FORWARD AND WERE REQUIRED TO BE REPLACED. CAUSE OF EVENT: THE FACILITY HAS USED A THIRD PARTY REPAIR FOR THE RICHARD WOLF WORKING ELEMENTS. DAMAGE ALSO INDICATED ROUGH HANDLING.

    Description of Event or Problem · 1

    DURING A FIBROID RESECTION PROCEDURE, THE EQUIPMENT WAS FUNCTIONING AND THE FIBROID WAS RESECTED. AT THE END OF THE CASE WHILE THE HYSTEROSCOPE WAS STILL IN THE PT, THE EQUIPMENT SPARKED NEAR THE SURGEON'S HAND, SMOKE WAS SEEN. INSTRUMENT WAS REMOVED FROM THE PT AND BROUGHT TO THE BACK TABLE FOR FURTHER INSPECTION. THE INSTRUMENT WAS OPENED AND CLOSED, SPARKED AGAIN AND FIRE WAS SEEN. THE FLAME EXTINGUISHED ITSELF AND THE EQUIPMENT WAS COMPLETELY UNPLUGGED. THE INSTRUMENT WAS VISIBLY MELTED AND CHARRED IN THE AREA WHERE IT WAS ON FIRE. THERE WAS NO HARM TO THE PT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR WORKING ELEMENT BIPOLAR WORKING ELEMENT GEI RICHARD WOLF MEDICAL INSTRUMENTS 8659.2351 1042689

    Patients

    Seq Age Sex Outcome Treatment
    1