BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 200

    MDR report key: 759433 · Received September 8, 2006

    Report

    Report Number
    9610614-2006-00018
    Event Type
    Other
    Date Received
    September 8, 2006
    Report Date
    September 8, 2006
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS EVALUATED BY ERBE ELECTROMEIDIZIN (I.E., OUR PARENT COMPANY ERBE). THE GENERATOR WAS FOUND TO BE WORKING AS INTENDED. NEVERTHELESS, AN ALIGNMENT (I.E. CALIBRATION) WAS PERFORMED ON THE UNIT TO ENSURE THAT ALL PARAMETERS WERE WITHIN SPECIFICATIONS. THEN A FOUR (4) HOUR BURN-IN STRESS TEST WAS COMPLETED ON THE ESU TO VERIFY SYSTEM STABILITY. FINALLY, A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR TO CONFIRM THAT ALL FEATURES ARE FUNCTIONING PROPERLY. THE UNIT WAS/IS WITHIN CALIBRATION PARAMETERS, FUNCTIONED/FUNCTIONS WELL UNDER STRESS, AND MET/MEETS SPECIFICATIONS. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENTS. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE SITUATION (FOR EXAMPLE, THE PHYSICIAN'S TECHNIQUE, PATIENT'S CONDITION, ETC.). HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE CUSTOMER WILL BE NOTIFIED WITH THE FINDINGS AND FOLLOW-UP IN-SERVICE WORK WILL BE PERFORMED AT THE FACILITY IF DEEMED NECESSARY. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. BASED UPON OUR FEED BACK FROM ERBE AFFILIATE, ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING/UPON POLYPECTOMY CASES WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR), PATIENT'S EXPERIENCED PERITONEAL IRRITATIONS AND EVEN PERFORATIONS AFTER REMOVAL OF SMALL/MUNDANE ADENOMAS. NOTE: THE EQUIPMENT WAS DISTRIBUTED BY ERBE ELECTROMEDIZIN (ERBE AFFILIATE), OUR PARENT COMPANY, TO A FOREIGN HOSPITAL. THEREFORE, THE P/N OF THE UNIT IS DIFFERENT THAN THE NUMBERS IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBOTOM ICC 200 ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH ICC 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other