BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CABLE FOR ENDOSCOPIC INSTRUMENTS

    MDR report key: 792984 · Received August 9, 2006

    Report

    Report Number
    9614969-2006-00001
    Event Type
    Other
    Date Received
    August 9, 2006
    Report Date
    July 14, 2006
    Manufacturer
    BOWA-ELECTRONIC GMBH & CO KG
    Product Code
    FFY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE DISTRIBUTORS REQUEST, WE FIRST MADE A VISUAL INSPECTION OF THE REFERENCED CABLE AND CAN ONLY CONFIRM THAT THE INTERNAL WIRES SEPARATED FROM THE INSTRUMENT PLUG. THIS CABLE, WITH LOT #230/628 IMPRINTED ON THE PLUG, WAS MANUFACTURED IN 07/2002 AND DELIVERED TO THE DISTRIBUTOR. WE WENT THROUGH ALL OF OUR PRODUCTION DOCUMENTS PERTAINING TO THIS PARTICULAR LOT NO. TO SEE IF THE RIGHT COMPONENTS/CABLE MATERIALS WERE USED AND CAN CONFIRM THAT EVERYTHING WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND WITH THE CORRECT MATERIALS. WE THOROUGHLY EXAMINED THE PLUG END AND WE FOUND NO DISCREPANCIES FROM THE MANUFACTURING. THE INSULATION WAS ALSO FOUND TO BE CORRECT WITH REGARD TO THE TYPE OF MATERIAL AND THICKNESS USED. WE ALSO CHECKED OUR DOCUMENTS WITH REGARD TO TESTS THAT WE PERFORMED AND CAN CONFIRM THAT ALL CABLES THAT WE MANUFACTURED, AS WELL AS THE ABOVE MENTIONED LOT/SHIPMENT OUR NUMBER 701-001 (OLD 360-030) AND, JARIT'S CATALOG NUMBER 600-290, ALWAYS UNDERGO INDIVIDUAL COMPLETE ELECTRICAL TESTING AND VISUAL INSPECTION. THE TESTING INCLUDES: AN ELECTRIC TESTING FOR SHORT CIRCUITING, A HIGH VOLTAGE TEST, A FUNCTION AND VISUAL TEST. THESE TESTS ARE ALWAYS PERFORMED ACCORDING TO DIN IEC 601. FROM 1995 TO THE PRESENT DATE, WE HAVE MANUFACTURED MONOPOLAR CABLES WITH THE SAME CABLE MATERIAL AND SPECIFICATIONS AS WERE USED ON THE CABLE INVOLVED IN THIS EVENT. IT IS OUR OPINION THAT YANKING ON THE CABLE, REGARDLESS IF IT'S THE INSTRUMENT PLUG OR THE GENERATOR PLUG, IN AN INAPPROPRIATE WAY, INSTEAD OF HOLDING THE PLUG AND REMOVING IT FROM THE INSTRUMENT WHICH IS THE STANDARD WAY, CAUSED THE ABOVE MENTIONED SEPARATION. PHOTOS ALSO MAKE IT VERY CLEAR THAT THE CABLE WAS TWISTED WHICH CAUSED THIS SEPARATION. WE WOULD ALSO LIKE TO CONFIRM THAT BESIDES THIS RETURN FROM OUR DISTRIBUTOR JARIT, WE HAVE HAD APPROX 17 OTHER CABLE RETURNS WITH SIMILAR SEPARATION CHARACTERISTICS. WE ALSO WOULD LIKE TO STATE THAT IN THE BEGINNING OF THE YEAR 2000, WE IMPLEMENTED AN ENGINEERING CHANGE WHEREBY THE SIZE OF THE GENERATOR PLUG WAS ENLARGED THEREFORE MAKING IT MORE LIKELY FOR ITS USER TO GRASP THE PLUG ITSELF AND NOT PULL THE CABLE WHEN REMOVING IT FROM THE GENERATOR. IN ADDITION A WHITE CAUTIONARY SLEEVE HAS BEEN ADDED TO THE CABLE DIRECTLY BEHIND THE GENERATOR PLUG THAT STATES "GRASP PLUG TO REMOVE CABLE. DO NOT PULL CORD", THUS MAKING THIS TYPE OF USER ERROR LESS LIKELY IN THE FUTURE. IN 2005, WE REPLACED THE WHITE WARNING NOTED ON THE CABLE AGAINST A RED TAG WITH THE SAME INSCRIPTION. CONCLUSION: THE RESULTS OF OUR INSPECTION INDICATE THAT THE CABLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS THAT NO MANUFACTURING DEFECTS WERE EVIDENT. IT IS OUR CONCLUSION THAT THIS CABLE WAS PRODUCED CORRECTLY AND FREE FROM ANY MANUFACTURING DEFECTS AND THAT THE EVENT WAS CAUSED BY USER ERROR. FINALLY IT IS OUR RECOMMENDATION THAT NO CORRECTIVE ACTION OF ANY KIND IS NECESSARY.

    Description of Event or Problem · 1

    DIRECTLY AT THE INSTRUMENT-LATERAL PLUG THE CABLE TORE WHILE IT STILL WAS ATTACHED TO THE DEVICE AS THE SURGEON WAS WORKING WITH IT. THIS LED TO SPARKING. NEITHER PT NOR PERSONNEL WERE HURT WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CABLE FOR ENDOSCOPIC INSTRUMENTS FFY BOWA-ELECTRONIC GMBH & CO KG 230/628

    Patients

    Seq Age Sex Outcome Treatment
    1