BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

    MDR report key: 17556539 · Received August 15, 2023

    Report

    Report Number
    MW5144584
    Event Type
    Other
    Date Received
    August 15, 2023
    Report Date
    August 10, 2023
    Manufacturer
    AESCULAP, INC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING USE, A NON-MEDTRONIC ACCESSORY WAS USED, THEN THE CABLE BROKE AND SPARKED. THERE WAS NO PATIENT INJURY. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT #MW5144585.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199068 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI AESCULAP, INC. US354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown