BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO DV

    MDR report key: 12332308 · Received August 17, 2021

    Report

    Report Number
    9610614-2021-00012
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 9, 2021
    Report Date
    August 17, 2021
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K133180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR (4) REQUEST WERE MADE TO THE MEDICAL FACILITY TO HAVE ERBE EVALUATE THE INVOLVED ESU, BUT TO NO AVAIL. THEREFORE, INSPECTION/TESTING WAS NOT POSSIBLE. NO ISSUES WERE FOUND WHEN REVIEWING THE DEVICE HISTORY RECORD OF THE INVOLVED DEVICE. BASED UPON THE REPORTED EVENT, IT APPEARS THAT THE PENCIL ELECTRODE WAS LAYED DOWN IN CLOSE CONTACT WITH THE PATIENT (AND NOT IN A SAFE PLACE). ADDITIONALLY, ACCIDENTAL OR ACTIVATION DUE TO A MALFUNCTION OF THE NON-ERBE PENCIL ELECTRODE WAS MOST LIKELY THE CAUSE OF INCIDENT (NOTE: THE MANUFACTURER OF THE PENCIL ELECTRODE, UNISURGE, SHOULD EVALUATE THEIR INSTRUMENT.). FINALLY, A WARNING IN THE ESU'S USER MANUAL EXPLICITLY WARNS AGAINST PLACING INSTRUMENTS ON A PATIENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY. THE ESU WAS USED WITH A NON-ERBE PENCIL ELECTRODE (MANUFACTURER UNISURGE, PART NUMBER/LOT NUMBER: INFORMATION NOT PROVIDED). THE PENCIL ACTIVATED ON ITS OWN CAUSING A BURN TO THE PATIENT'S SCROTUM. SUTURING OF THE AREA WAS REQUIRED TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED WITH THE DA VINCI SYSTEM WITHOUT ANY FURTHER PROBLEMS. THE ESU WAS DISTRIBUTED TO A HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227619 ERBE VIO DV ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO DV

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention