BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 16102186 · Received January 5, 2023

    Report

    Report Number
    9610614-2023-00002
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 3, 2022
    Report Date
    January 5, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS INSPECTED/TESTED. THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES AND A POWER OUTPUT CHECK. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE PROVIDED INFORMATION, IT APPEARS THAT THE PATIENT'S THIGH (AT THE BURN LOCATION) CAME INTO CONTACT WITH THE METAL LEG SUPPORT DURING THE PROCEDURE. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE USER MANUAL WARNS USERS THAT LEAKAGE CURRENT CAN FLOW THROUGH METALLIC, CONDUCTIVE OBJECTS DURING HF ACTIVATION, WITH THE RISK OF BURNS FOR THE PATIENT AND MEDICAL STAFF. THEREFORE, THE PATIENT MUST NOT HAVE CONTACT WITH ELECTRICALLY CONDUCTIVE OBJECTS. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A LAPAROSCOPIC SALPINGECTOMY. THE ESU WAS USED WITH A KARL STORZ (STORZ MO FORCEPS 3 MM AND STORZ BL NIPPER 3 MM). THESE WERE NON-ERBE ACCESSORIES. AN ERBE NESSY OMEGA RETURN ELECTRODE (PART NUMBER: 20193-083, LOT NUMBER: I220724-2408) WAS ATTACHED TO THE PATIENT'S LEFT THIGH. THE UNIT'S SETTINGS WERE AUTOCUT, EFFECT 2 AND PRECISESECT, EFFECT 1.5. DURING OR AFTER THE PROCEDURE, A BURN/NECROSIS WAS DISCOVERED ON THE PATIENT'S LEFT LATERAL THIGH CLOSE TO THE LEG SUPPORT. THE BURN IS SUSPECTED TO BE A SKIN LESION. THE LESION WAS DESCRIBED AS A 2ND DEGREE BURN APPROXIMATELY 0.5 CM. THE EXACT APPEARANCE OF THE BURN WAS NOT PROVIDED. FINALLY, NO INFORMATION WAS PROVIDED IN REGARDS TO THE TREATMENT OF THE PATIENT'S LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192072 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other