BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 350

    MDR report key: 1375561 · Received February 26, 2009

    Report

    Report Number
    9610614-2009-00003
    Event Type
    Other
    Date Received
    February 26, 2009
    Report Date
    February 26, 2009
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. SOME SERVICE WORK WAS PERFORMED ON THE GENERATOR AND ITS FOOTSWITCH, BUT IT WAS UNRELATED TO THE REPORTED ISSUE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE SITUATION. HOWEVER, IF THE ELECTROSURGICAL WORK WAS DONE IN A THIN WALLED AREA OF THE BOWEL, THE REMAINING WALL MAY NOT HAVE BEEN SUFFICIENT TO STAY INTACT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. THERE WAS A PERFORATION OF THE BOWEL. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THE ESU WAS DISTRIBUTED BY OUR PARENT COMPANY (ERBE ELECTROMEDIZIN (B)(4)) TO A (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBOTOM ICC 350 ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH ICC 350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI