BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES

    MDR report key: 740048 · Received July 14, 2006

    Report

    Report Number
    2430952-2006-00030
    Event Type
    Malfunction
    Date Received
    July 14, 2006
    Report Date
    July 13, 2006
    Manufacturer
    BOWA-ELECTRONIC
    Product Code
    FFY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHILE THE CAUTERY CORD WAS ATTACHED TO THE SCISSOR AND IN USE BY THE PHYSICIAN THE CORD AT THE END OF THE SCISSOR BROKE AND SPARKED. THE CORD WAS IMMEDIATELY REMOVED FROM THE FIELD. NO INJURY OCCURRED TO THE PT OR THE STAFF IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES JARIT ENDOSCOPIC INSTRUMENT FFY BOWA-ELECTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *