BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 200 S

    MDR report key: 3940833 · Received July 7, 2014

    Report

    Report Number
    9610614-2014-00009
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION INTO THE SITUATION WAS IMMEDIATELY UNDERTAKEN BY THE INVOLVED SALES REPRESENTATIVE AND ERBE TECHNICAL SUPPORT. IT WAS DISCOVERED THAT THE GENERATORS WERE BEING USED WITH OLYMPUS 4MM ACTIVE CABLES IN COMBINATION WITH 3 MM BOSTON SCIENTIFIC SNARES. THE CONNECTION BETWEEN THE TWO (2) NON-ERBE ACCESSORIES WAS VERY LOOSE. THIS CONDITION WOULD EXPLAIN THE REPORTED INTERMITTENT ERRATIC OUTPUT FROM THE ACCESSORIES. THEREFORE, LOANER ESUS AND COMPATIBLE ACCESSORIES WERE IMMEDIATELY PROCURED. THE NEXT DAY, CASE WORK WAS PERFORMED WITH DEMONSTRATION UNITS AND COMPATIBLE ACCESSORIES. THE MEDICAL STAFF (MULTIPLE PHYSICIANS, NURSES, ETC.) NOTICED AN IMMEDIATE DIFFERENCE AND ALL CASES WENT VERY WELL. AS A RESULT, IT APPEARS THAT THE USE OF THE DIFFERENT SIZE ACCESSORIES WAS MOST LIKELY THE CAUSE OF THE REPORTED ISSUES. NEVERTHELESS THE ESUS WERE THOROUGHLY INSPECTED/TESTED AT ERBE. TECHNICAL SAFETY CHECK WAS PERFORMED ONE EACH 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. ADDITIONALLY, THE OUTPUTS FROM THE ESUS WERE WITHIN SPECIFICATION AND CONSISTENT. NO ANOMALIES WERE FOUND IN THE REVIEW OF EITHER OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENTS. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC IS NOW CLOSING THE FILES ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) AS WELL AS ANOTHER ESU (SAME MODEL AND PART NUMBER), SERIAL NUMBER (B)(4) WERE INVOLVED IN A SERIES OF PT INCIDENTS OVER THE LAST SEVERAL MONTHS IN POLYPECTOMY PROCEDURES. THE SETTINGS OF THE ESUS WERE FORCED COAG, 25 WATTS, EFFECT 2. THERE WAS ONE (1) PERFORATION WHICH REQUIRED FURTHER INTERVENTION WORK, 10 POST POLYPECTOMY BLEEDS, AND THERE (3) POST POLYPECTOMY SYNDROMES. THE MEDICAL PERSONNEL REPORTED THAT THEY EXPERIENCED "RANDOM SURGE IN OUTPUT". NO SPECIFIC PT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393102 ERBE VIO 200 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention