BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G400

    MDR report key: 1192183 · Received October 8, 2008

    Report

    Report Number
    1192183
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN AND STAFF NOTED THAT THE COAGULATION CYCLE SEEMED TO BE SHORTER THAN USUAL, BUT SURGICALLY SEEMED TO BE WORKING. IT WAS NOTED THAT SURGEON HAD TO REPEAT TWICE ON ONE LIGAMENT. THEN WHEN TRYING TO CUT ANOTHER LIGAMENT, THE COAG CYCLE DID NOT RESULT IN COAGULATION AND THE PATIENT BEGAN TO BLEED ONCE THE CUT OCCURRED. THE SURGEON HAD TO CHANGE TO A DIFFERENT SURGICAL APPROACH TO CONTROL THE BLEEDING AND COMPLETE THE SURGERY. THE CONTROL SETTING WAS AT 35 (NORMAL) BUT HAD BEEN ADJUSTED UP TO 45 DURING CASE.====================== MANUFACTURER RESPONSE FOR ESU, G400======================COMPANY REP. WAS PRESENT IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G400 ESU GEI GYRUS MEDICAL, INC. G400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR