BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC MONOPOLAR CABLE

    MDR report key: 227935 · Received June 18, 1999

    Report

    Report Number
    2430952-1999-00002
    Event Type
    Malfunction
    Date Received
    June 18, 1999
    Date of Event
    June 1, 1999
    Report Date
    June 10, 1999
    Manufacturer
    BOWA-ELECTRONIC GMBH
    Product Code
    HFG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SPARKING AND SMALL FIRE AT EQUIPMENT END OF ELECTROSURGICAL CABLE. THERE WAS NO PT OR OPERATOR INJURY AS A RESULT OF THIS EVENT. ON JUNE 14, 1999, IMPORTER REC'D A MEDWATCH REPORT FROM THE USER FACILITY, PERTAINING TO AN EVENT WITH A JARIT MEDICAL DEVICE. JARIT SURGICAL INSTRUMENTS (J. JAMNER SURGICAL INSTRUMENTS) IS AN INITIAL DISTRIBUTOR OF MEDICAL DEVICES. AS SUCH, THEY HAVE COMPLETED SECTION F OF FORM 3500A, A COPY OF WHICH IS ENCLOSED ALONG WITH THE USER FACILITY'S MEDWATCH REPORT. IN ACCORDANCE WITH FDA PROCEDURES, COPIES OF BOTH THE USER FACILITY'S REPORT AND IMPORTER'S FORM 3500A HAVE BEEN FORWARDED TO THE MFR OF THIS DEVICE, BOWA-ELECTRONIC GMBH, NEHRENER STRABE 4-6, POSTFACH 70/PLZ 72807, D-72810 GOMARINGEN, GERMANY. THE HOSP REPORTED A DEVICE MALFUNCTION WITH A LAPAROSCOPIC MONOPOLAR CABLE. THERE WAS NO PT INJURY. THE DEVICE INVOLVED WAS SENT TO THE MFR ON JUNE 14, 1999 FOR THEIR EVAL. IN ACCORDANCE WITH FDA REGULATIONS, 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 LAPAROSCOPIC MONOPOLAR CABLE LAPAROSCOPIC MONOPOLAR CABLE HFG BOWA-ELECTRONIC GMBH * 97-12

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other