BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENWALD SURGICAL

    MDR report key: 21069421 · Received January 3, 2025

    Report

    Report Number
    1818662-2025-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    October 11, 2024
    Report Date
    January 2, 2025
    Manufacturer
    GRACE MANUFACTURING / GREENWALD SURGICAL
    Product Code
    FBJ
    UDI-DI
    10801334001278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INVESTIGATION CAN BE COMPLETED.

    Description of Event or Problem · 0

    FROM OUR CUSTOMER: "DURING A CYSTOSCOPY WITH BLADDER BIOPSY PROCEDURE, THE MD NOTED THAT THE BUGBEE ELECTRODE WAS NOT FUNCTIONING WHEN ACTIVATED. THE RN CHECKED THE CORD AND WHILE TRYING TO TROUBLESHOOT, THE END OF THE CORD BECAME DISCONNECTED AND THE RN NOTED THAT THE CORD HAD A SLIGHT "BURNED" SMELL TO IT. A NEW CORD WAS OPENED TO THE SURGICAL FIELD AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. AT NO POINT DID ANYONE SEE ANY SMOKE OR FIRE, THE RN JUST NOTED AN ODD SMELL WHEN HE SNIFFED THE CORD. REPORTED TO FDA - (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775314 GREENWALD SURGICAL MONOPOLAR CORD M25 77000-01 FBJ GRACE MANUFACTURING / GREENWALD SURGICAL 77000-01 103636-000 10801334001278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown