BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN BIOSURGICAL MONOPOLAR CORD

    MDR report key: 932179 · Received October 8, 2007

    Report

    Report Number
    1061133-2007-00002
    Event Type
    Malfunction
    Date Received
    October 8, 2007
    Date of Event
    July 6, 2006
    Report Date
    October 1, 2007
    Manufacturer
    AMERICAN BIOSURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY'S CABLES MANUFACTURED ARE TESTED AND INSPECTED TO APPLICABLE INTERNATIONAL PERFORMANCE STANDARDS PRIOR TO SHIPMENT. THIS IS THE FIRST OF SUCH A REPORT TO THE COMPANY FOR THIS CABLE TYPE. THE MANUFACTURER WAS ABLE TO OBTAIN THE SUSPECT CABLE FOR ANALYSIS FROM THE END-USER. THE CABLE WAS DISSECTED AND MICROSCOPICALLY EXAMINED. FINDINGS DURING THE ANALYSIS WERE PHOTOGRAPHED. IT WAS DETERMINED THAT THE CABLE INTERNAL COPPER WIRES SEVERED PROXIMAL TO THE OVERMOLDED THERMOPLASTIC CONNECTOR HUB. THIS IS KNOWN TO OCCUR FROM USER MISHANDLING SUCH AS IMPROPER PULLING ON THE CABLES DURING UNPLUGGING FROM EQUIPMENT RATHER THAN PROPERLY GRASPING THE CONNECTOR SHELL.CABLE WIRES ARE ALSO SUBJECT TO POTENTIAL BREAKAGE FROM KINKING OR SHARP BENDS DURING USE. THE PRODUCT LABELING CONTAINS APPROPRIATE CAUTIONARY LANGUAGE IN THIS REGARD, INCLUDING THAT THE USER INSPECT CABLES FOR DAMAGE PRIOR TO EACH USE. THE COMPANY HAS CHANGED THE THERMOPLASTIC OVERMOLDING USED TO A SOFTER MATERIAL AND ENHANCED THE STRAIN RELIEF FOR POTENTIALLY PROVIDING GREATER CABLE AND WIRE FLEXIBILITY DURING BENDING AND TWISTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ELECTRO-SURGICAL PROCEDURE, THAT THE MONOPOLAR CORD SPARKED AND EMITTED A BLUE FLAME AT THE CONNECTOR HUB. THE CABLE WAS REMOVED FROM SERVICE AND NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN BIOSURGICAL MONOPOLAR CORD MONOPOLAR CABLE/CORD GEI AMERICAN BIOSURGICAL, INC. 005073

    Patients

    Seq Age Sex Outcome Treatment
    1 YR