BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM AEM HANDLE ASSEMBLY

    MDR report key: 761430 · Received September 15, 2006

    Report

    Report Number
    1722040-2006-00006
    Event Type
    Injury
    Date Received
    September 15, 2006
    Date of Event
    August 15, 2006
    Report Date
    September 14, 2006
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED HANDLE WAS VISUALLY INSPECTED UNDER MAGNIFICATION, WITH NO DAMAGE FOUND TO THE SHAFT OR TIP AREA. THE UNIT WAS THEN ELECTRICALLY TESTED AND PASSED ALL TESTS INCLUDING INNER INSULATION DIELECTRIC STRENGTH, OUTER INSULATION DIELECTRIC STRENGTH AND SHIELD CONTINUITY. A REVIEW WAS CONDUCTED OF LOT GK. NO OTHER ISSUES OF ANY NATURE HAVE BEEN REPORTED SINCE ITS MFR IN 11/2001. NATURE OR CAUSE OF THE REPORTED INJURY COULD NOT BE DETERMINED FROM THE AVAILABLE DATA. ADDITIONAL ANALYSIS FOR A SIMILAR EVENT MAY BE FOUND IN MDR 1722040-2003-00003.

    Description of Event or Problem · 1

    SALES REP REPORTED <1CM BURN TO DISTAL SMALL BOWEL DURING LAPAROSCOPIC OVARIAN CYSTECTOMY WITH OOPHRECTOMY. CONSULTING GENERAL SURGEON ADVISED TO "OVERSEW". PT IS RECOVERING WITHOUT ANY SPECIAL TREATMENT. SURGEON BELIEVED THE BURN CAME FROM THE SHAFT OF THE INSTRUMENT BECAUSE HE/SHE WAS "NEVER IN THE AREA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM AEM HANDLE ASSEMBLY LAPAROSCOPIC ELECTROSURGICAL DEVICE GEI ENCISION, INC. ES5700S GK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention THE HOSP.| ES0102, DISPOSABLE 3/4" SCISSORS INSERT WAS NOT| RETURNED FOR EVAL BECAUSE IT WAS DISPOSED OF BY