BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE USA, INC.

    MDR report key: 167546 · Received May 16, 1998

    Report

    Report Number
    9610614-1998-00001
    Event Type
    Injury
    Date Received
    May 16, 1998
    Date of Event
    March 4, 1998
    Report Date
    May 15, 1998
    Manufacturer
    ERBE USA INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP / ADDITIONAL TRAINING WAS PERFORMED BY REP ON MARCH 5, 1998. THE TRAINING WAS A FULL DAY ON INSTRUCTION, REEMPHASIS ON THE MATERIAL COVERED DURING IN-SERVICE TRAINING PLUS THE FOLLOWING AREA'S WERE COVERED IN-DEPTH CLINICAL APPLICATIONS, APC PRINCIPLES, PROCEDURES, TECHNIQUES, TROUBLESHOOTING AND PRECAUTIONS. ALL PHYSICIANS THAT PERFORM PROCEDURES AT THIS ACCOUNT WERE PRESENT FOR THIS TRAINING.

    Description of Event or Problem · 1

    AFTER COMPLETION OF A ROUTINE POLYPECTOMY IN THE RIGHT COLON AREA, THE PT RECOVERY WAS FAVORABLE. SEVERAL HOURS LATER THE PT WAS ADMITTED TO THE ER WITH BOWEL PERFORATION. SURGICAL INTERVENTION WAS REQUIRED TO REPAIR THE PERFORATION. PT RECOVERED WITHOUT FURTHER COMPLICATIONS. THE ICC SYSTEM WAS SET CORRENCTLY AT 150 WATTS, EFFECT 3 USING ENDOCUT MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE USA, INC. ELECTROSURGICAL GENERATOR GEI ERBE USA INC. ICC 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R