BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 200 EA

    MDR report key: 8564402 · Received April 30, 2019

    Report

    Report Number
    9610614-2019-00012
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    February 26, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND 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. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. HOWEVER, THE PATIENT'S CONDITION OF HAVING A BROAD BASED POLYP WAS A KEY FACTOR IN THE OUTCOME. SPECIFICALLY UPON THE INTERVENTION WORK, THE REMAINING TISSUE OF THE BOWL DID NOT STAY INTACT AS A RESULT OF THE NECROSIS AT THE ABLATION SITE AND THEN THE DELAYED PERFORATION. IN CONCLUSION, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. NO TRENDS HAVE BEEN IDENTIFIED. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT WAS INVOLVED IN A PATIENT INCIDENT UPON A POLYPECTOMY. THE ESU WAS USED TO REMOVE A BROAD BASED POLYP. THE GENERATOR WAS USED WITH AN ERBE RETURN ELECTRODE CABLE (PART NUMBER 20194-058, LOT NUMBER NOT APPLICABLE) AND AN ERBE NESSY OMEGA RETURN ELECTRODE (PART NUMBER 20193-082, LOT NUMBER 160810-0816). THE RETURN ELECTRODE WAS PLACED ON THE PATIENT'S RIGHT THIGH. NO INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY USED OR THE SPECIFIC SETTINGS EMPLOYED. DURING THE POLYPECTOMY, THERE HAD BEEN NO ABNORMALITIES OR DETECTABLE PERFORATION. HOWEVER DAYS LATER, THE PATIENT CAME BACK WITH ABDOMINAL PAIN. NECROSIS (INCLUDING A DELAYED PERFORATION) WAS FOUND AT THE ABLATION SITE OF THE POLYP. TO ADDRESS THE ISSUE, THE PATIENT UNDERWENT A PARTIAL RESECTION OF THE TRANSVERSE COLON WITH ADDITIONAL HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358943 ERBE ICC 200 EA ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 200 EA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R