BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 4834976 · Received June 1, 2015

    Report

    Report Number
    9610614-2015-00006
    Event Type
    Other
    Date Received
    June 1, 2015
    Date of Event
    April 22, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE PT INCIDENT SUCH AS THE PROCEDURE BEING LONG, ELDERLY/OBESE PT'S BEING MORE SUSCEPTIBLE TO PRESSURE TO THE SKIN, POSSIBLE REACTION TO DISINFECTANT USED AT THE SITE, ETC. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. 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 A PT INCIDENT OCCURRED DURING A KNEE ENDOPROSTHESIS WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE PT WAS IN A SUNPINE POSITION DURING THE SURGERY AND THE SURGERY WAS APPROXIMATELY 100 MINUTES IN DURATION. UPON THE RIGHT KNEE REPLACEMENT ON AN OBESE PT, NECROSIS WAS DISCOVERED ON THE PT'S BUTTOCKS. NO FURTHER INFO REGARDING THE PT 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
    354137 ERBE VIO 300 D ELECTROSURGICAL GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other