BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC

    MDR report key: 274200 · Received April 18, 2000

    Report

    Report Number
    9610614-2000-00002
    Event Type
    Injury
    Date Received
    April 18, 2000
    Date of Event
    March 14, 2000
    Report Date
    April 18, 2000
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 3-20-2000, ERBE SALES REPRESENTATIVE WAS INFORMED ABOUT A PERFORATION BY DR. THE DOCTOR WAS USING AN ARGON PLASMA COAGULATOR (APC) MODEL 300 (NOTE: DEVICE WAS USED IN ASSOCIATION WITH AN ELECTROSURGICAL GENERATOR) TO COAGULATE A TELANGIETASIA IN THE RIGHT COLON. DURING THE PROCEDURE THE COLON WALL WAS PERFORATED (NOTE: THE EQUIPMENT WAS SET AT 40 WATTS WITH A FLOW OF 0.8 LITERS PER MINUTE). SURGICAL INTERVENTION WAS REQUIRED AT THE TIME. PT RECOVERED. DOCTOR HAS USED THE EQUIPMENT ON OTHER PTS. MOST RECENTLY DOCTOR USED THE EQUIPMENT WITH ANOTHER DOCTOR TO ABLATE AN ESOPHEGEAL TUMOR ON 03/20/2000 WITH NO PROBLEMS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC ARGON PLASMA COAGULATOR SYSTEM GEI ERBE USA, INC. APC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention