BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 50 C

    MDR report key: 4170595 · Received October 1, 2014

    Report

    Report Number
    9610614-2014-00013
    Event Type
    Other
    Date Received
    October 1, 2014
    Date of Event
    June 19, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K101108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM (INCLUDING THE BIPOLAR FORCEPS) WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ALL OF THE GENERATOR'S OUTPUT POWERS WERE WITHIN SPECIFICATION (+/- 20% PER STANDARDS). HOWEVER, THE TISSUE EFFECT CAN BE SLIGHTLY DIFFERENT AT THE UPPER AND LOWER LIMITS OF ANY SETTING. THEREFORE, A WARNING IN THE USER MANUAL STATES "SET POWER AS LOW AS POSSIBLE RELATIVE TO THE REQUIRED SURGICAL EFFECT. IF THE REQUIRED SURGICAL EFFECT IS NOT ACHIEVED, INCREASE THE POWER." NO TRENDS HAVE BEEN IDENTIFIED WITH THS INCIDENT. ERBE USA, INC. IN NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED DURING A PHACOEMULSIFICATION. THE ELECTROSURGICAL UNIT (ESU/GENERATOR) AND BIPOLAR FORCEPS WERE USED IN THE CATARACT SURGERY TO EMULSIFY THE EYE'S INTERNAL LENS. THE ESU'S INITIAL SETTINGS WERE BIPOLAR SOFT COAG, 8 WATTS. OVER THE COURSE OF THE PROCEDURE THE SETTINGS WERE ADJUSTED BY THE DOCTOR TO 4-5 WATTS AND THEN 2 WATTS TO OBTAIN "NORMAL" COAGULATION RESULTS. THE PHYSICIAN FELT THAT THE TISSUE EFFECT WAS GREATER THAN AN OLDER ERBE MODEL (ERBOTOM ICC 50) WITH THE SAME SETTINGS. AFTER THE PROCEDURE, THE PATIENT'S CORNEA WAS BURNED WHICH RESULTED IN ASTIGMATISM AND IMPAIRED VISION. NO FURTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED. NOTE: THE ESU IS SIMILAR TO A MODEL DISTRIBUTED IN THE UNITED STATES. IT WAS DISTRIBUTED BY OUR PARENT COMPANY (B)(4) TO A HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613144 ERBE VIO 50 C ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 50 C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability