BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE USA, INC.

    MDR report key: 694746 · Received March 21, 2006

    Report

    Report Number
    694746
    Event Type
    Injury
    Date Received
    March 21, 2006
    Date of Event
    March 16, 2006
    Report Date
    March 21, 2006
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN ENDOSCOPY FOR GI PROCEDURE AND WENT TO RECOVERY ROOM. SHORTLY AFTER PROCEDURE, SHE COMPLAINED OF CHEST PAIN. X-RAY SHOWED RECTAL PERFORATION. PATIENT TO O.R. FOR REPAIR. PHYSICIAN FELT THE PERFORATION WAS DUE TO MALFUNCTIONING COAGULATOR. THE STAFF USED THE COAGULATOR ON ANOTHER PATIENT BEFORE THIS INCIDENT WAS DISCOVERED. THERE WERE NO PROBLEMS WITH THE MACHINE. BIO-MED CHECKED THE CABLES, THEY WERE WORKING FINE. THE COAGULATOR IS BEING SENT TO THE MANUFACTURER FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE USA, INC. ESU, COAGULATOR GEI ERBE USA, INC. V10300D *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R