BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 300

    MDR report key: 2081351 · Received April 28, 2011

    Report

    Report Number
    9610614-2011-00005
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU) SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. NO ISSUES WERE FOUND WITH THE SYSTEM THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE (NOTE: SOME UNRELATED SERVICE WORK WAS PERFORMED ON THE COAGULATOR.). A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU DID NOT REVEAL ANY ANOMALIES. DUE TO THE DIGESTIVE PROCESSES OF EATING BETWEEN PROCEDURES, IT APPEARS THAT COMBUSTIBLE GASES (E.G. METHANE AND/OR HYDROGEN) WERE PRESENT IN THE BOWEL AT SUCH A CONCENTRATION THAT WHEN DIATHERMY WAS APPLIED TO ADDRESS THE BLEEDING AN EXPLOSION OCCURRED. A WARNING IN THE USER MANUALS STATES THAT WHEN USING ELECTROSURGERY IN THE GASTROINTESTINAL TRACT, THERE MUST NOT BE ANY COMBUSTIBLE OR EXPLOSIVE ENDOGENOUS GASES PRESENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WILL BE OFFERED TO THE MEDICAL STAFF AT THE HOSPITAL. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS SITUATION. ERBE (B)(4) IS NOW CLOSING THIS FILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A COLONOSCOPY IN THE MORNING AT AN ENDOSCOPY CENTER. HOWEVER, THE PT EXPERIENCED POST-PROCEDURAL BLEEDING AND WENT TO THE HOSPITAL. THEREFORE, A SECOND COLONOSCOPY WAS PERFORMED LATER THAT DAY AT THE MEDICAL CENTER WITH THE ERBE EQUIPMENT [I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL (APC 300 WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) MODEL ICC 200 E/A, PART NUMBER 10128-205, AND (B)(4)] TO ADDRESS THE BLEEDING. UNFORTUNATELY, THE PT ATE BETWEEN THE PROCEDURES. AS A RESULT UPON ACTIVATION OF THE COAGULATOR, A BOWEL EXPLOSION OCCURRED WHICH RESULTED IN A PERFORATION. THE PT UNDERWENT SURGERY TO HAVE A TEMPORARY COLOSTOMY AND REPAIR OF THE COLON. THE PT WAS RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC 300 ARGON PLASMA COAGULATOR GEI ERBE ELECTROMEDIZIN GMBH APC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention