BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 21851197 · Received April 16, 2025

    Report

    Report Number
    9610614-2025-00020
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS NOT MADE AVAILABLE TO ERBE FOR INSPECTION/TESTING. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE ESU. DUE TO THE LACK OF INFORMATION, WE CAN ONLY SPECULATE AS TO THE CAUSE OF THE SKIN LESION ON THE NEWBORN'S WRIST. THE DESCRIPTION OF THE LESION BEING YELLOW IN COLOR AND ITS SIZE SUGGEST THAT IT IS A HEMATOMA AND NOT RELATED TO THE ELECTRICAL OUTPUT OF THE ESU. HOWEVER, IF THE LESION WAS/IS A BURN CAUSED BY LEAKAGE CURRENT, THE BABY'S WRIST WOULD HAVE HAD CONTACT WITH METALLIC PARTS. THE ESU'S USER MANUAL EXPLICITLY WARNS AGAINST CONTACT BETWEEN THE PATIENT AND METALLIC OBJECTS. THERE IS ALSO A WARNING REGARDING THE USE OF MONITORING ELECTRODES. 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 THE TREATMENT OF A PULMONARY INFECTION. SPECIFIC INFORMATION REGARDING THE ESU'S SETTINGS AND ANY OTHER DEVICES USED WAS NOT PROVIDED. PRESUMABLY AFTER THE PROCEDURE, A YELLOWISH LESION MEASURING 1 CM² WAS FOUND ON THE SKIN OF THE INFANT'S WRIST. NO INFORMATION WAS PROVIDED INVOLVING ANY TREATMENT GIVEN TO ADDRESS THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105828 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 22 DA Male Other