BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 200 E

    MDR report key: 1036690 · Received April 30, 2008

    Report

    Report Number
    9610614-2008-00008
    Event Type
    Injury
    Date Received
    April 30, 2008
    Date of Event
    July 1, 2007
    Report Date
    April 30, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OVER 8 MONTHS AGO. IN THAT TIME PERIOD, THE ESU HAD BEEN USED REPEATEDLY WITHOUT ANY PROBLEMS OR EVENTS. THEREFORE THE CUSTOMER DECLINED OUR OFFER TO HAVE THE GENERATOR INSPECTED/TESTED (I.E., THEY ARE CONFIDENT THAT THE UNIT HAD NOTHING TO DO WITH THE INCIDENT). NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) FOR THE INVOLVED ESU. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE SITUATION. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE BY ERBE USA AS TO THE CAUSE OF THE REPORTED EVENT. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE TRAINING WILL BE OFFERED TO THE CUSTOMER. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROSURGICAL GENERATOR WAS USED IN A POLYPECTOMY PROCEDURE ON A MORBIDLY OBESE FEMALE. THE PHYSICIAN NOTED THAT THERE WAS "TOO MUCH BURN" AND A "BURN ARTIFACT". SUBSEQUENTLY, A PERFORATION WAS DETECTED AFTER 24 HOURS AND SURGERY WAS THEN PERFORMED TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention