BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CABLE

    MDR report key: 299380 · Received October 6, 2000

    Report

    Report Number
    2430952-2000-00005
    Event Type
    Other
    Date Received
    October 6, 2000
    Report Date
    October 5, 2000
    Manufacturer
    BOWA-ELECTRONIC GMBH
    Product Code
    KNF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "SPARKING" FROM THE MONOPOLAR CABLE. ON 9/21/00, STATESIDE DISTRIBUTOR RECEIVED NOTIFICATION VIA LETTER FROM THEIR OVERSEAS DISTRIBUTOR, AMCO, INC., PERTAINING TO AN EVENT AT AN OVERSEAS HOSP, WITH A JARIT MEDICAL DEVICE. THE DISTRIBUTOR REPORTED A DEVICE MALFUNCTION WITH A LAPAROSCOPIC MONOPOLAR CABLE. THERE WAS NO PT OR PERSONNEL INJURY. JARIT SURGICAL INSTRUMENTS ( J. JAMNER SURGICAL INSTRUMENTS) IS AN INITIAL DISTRIBUTOR OF MEDICAL DEVICES. AS SUCH, CO HAS COMPLETED SECTION F OF FORM 3500A. REGARDING THE REPORTING OF THIS EVENT, THE DISTRIBUTOR AND HOSP HAD NO RECORD OF SPECIFIC INFO REGARDING THIS EVENT. AFTER REVIEWING THE REGULATIONS, STATESIDE DISTRIBUTOR CONCLUDED TO SUBMIT THIS REPORT AS A CAUTIONARY MEASURE. SECTIONS, B, D, AND E OF FORM 3500A HAVE BEEN COMPLETED WITH THE INFO MADE AVAILABLE BY THE DISTRIBUTOR. IN ACCORDANCE WITH FDA PROCEDURES, COPIES OF A COMPLETED FORM 3500A HAVE BEEN FORWARDED TO THE MFR OF THIS DEVICE, BOWA-ELECTRONIC GMBH, NEHRENER STRASSE 4-6, POSTFACH 70/PLZ 72807, D-72810 GOMARINGEN, GERMANY. THE MFR WILL COMPLETE THE APPLICABLE SECTIONS OF THE FORM 3500A AND FORWARD ALL COPIES TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CABLE * KNF BOWA-ELECTRONIC GMBH * 12-97

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other