BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 S

    MDR report key: 5790406 · Received July 13, 2016

    Report

    Report Number
    9610614-2016-00016
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 16, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT. 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 ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) FOR THE GENERATOR. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE PATIENT INCIDENT (E.G., DISEASE STATE OF THE PATIENT- SIZE AND LOCATION OF POLYP, ETC.). HOWEVER IT APPEARS THAT DURING OR UPON THE REMOVAL OF THE POLYP, THE REMAINING MYOMETRIUM AND THE SIGMOID COLON DID NOT STAY INTACT. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED AND 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 USED IN A HYSTEROSCOPY TO REMOVE AN INTRAUTERINE POLYP. THE ESU WAS USED IN CONJUNCTION WITH EQUIPMENT MANUFACTURED BY STORZ [I.E., RESECTOSCOPE, PART NUMBER (P/N) 27040 E/S; RESECTION SNARE, P/N 27040G; BALL ELECTRODE, P/N 27040N; OPTIC, P/N 27005 BA; AND INSTRUMENT WITH BENT TIP, P/N 27040L]. DURING THE RESECTION/REMOVAL OF THE POLYP, THE PATIENT COMPLAINED OF PAIN. UPON THE HYSTEROSCOPY, A PERFORATION OF THE UTERUS AND SIGMOID COLON WAS DETECTED. THE PERFORATION WAS 6 CM X 0.5 CM. SURGICAL INTERVENTION WAS PERFORMED TO ADDRESS THE PERFORATION WHICH PROLONGED THE PATIENT'S STAY AT THE HOSPITAL. NOTE: THE ESU WAS DISTRIBUTED BY AN ERBE ELEKTROMEDIZIN (B)(4) SUBSIDIARY TO A HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445905 ERBE VIO 300 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 S

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R