BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEYLAB ELECTROSURGICAL PENCIL

    MDR report key: 412630 · Received August 22, 2002

    Report

    Report Number
    1717344-2002-00068
    Event Type
    Injury
    Date Received
    August 22, 2002
    Date of Event
    July 27, 2002
    Report Date
    August 8, 2002
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ENCLOSED MEDWATCH WAS REC'D INDICATING "DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE USING CAUTERY AND CAUTERY UTILIZED TO CAUTERIZE BLEEDER POINTS AT TRACOR SITES. ATTEMPTED TO USE A 2ND TIME TO CAUTERIZE BLEEDING AND DID NOT WORK. HAND PIECE AND CORD CHANGED. NO FURTHER PROBLEMS. AT THE END OF THE CASE 1" BY 1/2" BLACKENED AREA NOTED ON RIGHT ANTERIOR ABDOMINAL WALL. AREA EXCISED AND SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB ELECTROSURGICAL PENCIL ELECTROSURGICAL PENCIL GEI VALLEYLAB E2515H-GNSB 59659

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR