BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSHEARS

    MDR report key: 17557 · Received July 14, 1994

    Report

    Report Number
    17557
    Event Type
    Other
    Date Received
    July 14, 1994
    Date of Event
    February 24, 1994
    Report Date
    March 4, 1994
    Manufacturer
    UNITED STATED SURGICAL CORP.
    Product Code
    KNF
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPY PROCEDURE AUTO SUTURE ENDOSHEARS WERE USED - UPON COAGULATION OF INTENDED TISSUE, SURROUNDING TISSUE TOUCHING INSULATED PORTION OF ENDOSHEARS WAS BURNED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSHEARS DISPOSABLE INSTRUMENT WITH UNIPOLAR CAUTER KNF UNITED STATED SURGICAL CORP. 176643 P3M151L

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other