BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELMED

    MDR report key: 77340 · Received February 21, 1997

    Report

    Report Number
    77340
    Event Type
    Malfunction
    Date Received
    February 21, 1997
    Manufacturer
    ELMED INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ELECTRICAL SURGICAL UNIT PROBE, BIPOLAR, ACTIVATED IN THE HANDSWITCH POSITION. OPERATION MANUAL PG3 STATES THE GENERATOR WILL ONLY BE ACTIVATED USING SPECIAL BICOMATIC FORCEPS WHICH WERE NOT IN USE. BIPOLAR PROBE#5970 WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELMED ESU GEI ELMED INC. MC/MS M/M *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other