BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO DV

    MDR report key: 21571763 · Received March 11, 2025

    Report

    Report Number
    9610614-2025-00015
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K150364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED VIO DV ELECTROSURGICAL UNIT (ESU) WAS NOT PROVIDED TO ERBE FOR AN EVALUATION (I.E., A TECHNICAL SAFETY CHECK). NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE ERBE ESU. ALSO, INFORMATION REGARDING THE INSPECTION AND/OR TESTING OF THE DA VINCI ROBOT, MONOPOLAR CURVED SCISSORS, FENESTRATED BIPOLAR FORCEPS, OR NEUTRAL ELECTRODE WAS NOT PROVIDED TO ERBE. DUE TO THE LACK OF INFORMATION, NO DETERMINATION COULD BE MADE TO THE CAUSE(S) OF THE REPORTED INCIDENT. 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 DA VINCI ROBOT THAT INCLUDED THE ERBE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A HYSTERECTOMY. THE EVENT WAS REPORTED TO HAVE OCCURRED TOWARDS THE END OF THE OPERATION. THE EQUIPMENT WAS USED WITH MONOPOLAR CURVED SCISSORS AND FENESTRATED BIPOLAR FORCEPS (NOTE: INFORMATION REGARDING THE MANUFACTURER OF THE ACCESSORIES WAS NOT PROVIDED.). NO INFORMATION WAS CONVEYED TO ERBE REGARDING THE ESU SETTINGS USED DURING THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE DA VINCI ROBOT WAS NOT FUNCTIONING PROPERLY DURING THE OPERATION, BUT NO SPECIFIC DETAILS WERE FURNISHED. NEVERTHELESS, A SKIN LESION WAS REPORTED TO HAVE OCCURRED UNDER THE NEUTRAL ELECTRODE (NOTE: NO INFORMATION WAS SPECIFIED AS TO WHO MANUFACTURED THE NEUTRAL ELECTRODE.). THE PLACEMENT OF THE NEUTRAL ELECTRODE WAS NOT PROVIDED, NOR WAS THE APPEARANCE, SIZE, SHAPE, ETC. OF THE SKIN LESION GIVEN. FINALLY, ERBE DOESN'T KNOW IF ANY TREATMENT WAS NECESSARY TO ADDRESS THE SKIN LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337361 ERBE VIO DV ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO DV

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other