BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 S

    MDR report key: 15671856 · Received October 26, 2022

    Report

    Report Number
    9610614-2022-00038
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 26, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE ESU WAS PERFORMED BY THE HOSPITAL. THEY REPORTED THAT THE ALL OF THE GENERATOR'S FEATURES WERE FUNCTIONING PROPERLY. A REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR) WAS COMPLETED AND NO ANOMALIES WERE FOUND. BASED UPON THE PROVIDED INFORMATION, IT APPEARS THAT AN UNINTENTIONAL ACTIVATION OF AN INSTRUMENT ON OR NEAR THE PATIENT CAUSED THE PATIENT INCIDENT. THE ESU USER MANUAL EXPLICITLY STATES THAT INSTRUMENTS MUST BE PLACED IN A SAFE PLACE: STERILE, DRY, NON-CONDUCTIVE, EASILY VISIBLE. STORED INSTRUMENTS MUST NOT COME INTO CONTACT WITH THE PATIENT, MEDICAL STAFF OR FLAMMABLE MATERIALS. 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 AN INTRAOPERATIVE PROCEDURE. NO SPECIFIC INFORMATION WAS PROVIDED ON THE TYPE OF PROCEDURE, ACCESSORIES USED, SETTINGS OF THE UNIT, ETC. DURING THE SURGERY, A HANDLE WAS INADVERTENTLY ACTIVATED BY A FOOTSWITCH (NOTE: THE SURGEON HAD INTENDED TO ACTIVATE FORCEPS.). THIS CAUSED A BURN TO THE PATIENT. THE SPECIFICS INVOLVING THE TISSUE DAMAGE (I.E., THE SEVERITY OF THE BURN), PATIENT'S CONDITION, INTERVENTION WORK, ETC. WAS NOT MADE AVAILABLE TO ERBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801720 ERBE VIO 300 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 S

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other