BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEM DISPOSABLE ELECTRODE, L-DIAMOND, 35CM

    MDR report key: 1562865 · Received December 18, 2009

    Report

    Report Number
    1722040-2009-00003
    Event Type
    Other
    Date Received
    December 18, 2009
    Date of Event
    April 8, 2008
    Report Date
    December 11, 2009
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K072789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SPARKING ON THE TIP WAS REPLICATED IN THE LAB, UNDER CERTAIN SIMULATED CONDITIONS, ALLOWING ESCHAR BUILDUP ON THE TIP INSULATION MATERIAL. SUCH ESCHAR WOULD OCCUR IN THE AREA OF THE SURGEON'S FIELD OF VIEW, CAN OCCUR ON THE TIP IN NORMAL USE, AND CAN BE CLEANED OFF BY THE SURGEON.

    Description of Event or Problem · 1

    REPORTED SMALL BURN TO LIVER DURING A LAP CHOLE; NO PATIENT MEDICAL INTERVENTION NEEDED AND HOSPITAL DID NOT DO AN INCIDENT REPORT. SALES REP THOUGHT THIS WAS DUE TO INSTRUMENT THAT CAUSED BURN. FURTHER PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM DISPOSABLE ELECTRODE, L-DIAMOND, 35CM ELECTROSURGICAL CUTTING AND COAGULATION GEI ENCISION, INC. ES0311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other USED W/ ES1300 DISPOSABLE HANDSWITCHING HANDPIECE.