BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE VIO 3

    MDR report key: 22554672 · Received July 21, 2025

    Report

    Report Number
    9610614-2025-00043
    Event Type
    Death
    Date Received
    July 21, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED (NOTE: THE ERBE TRISECT RAPIDE INSTRUMENT WAS DISPOSED OF AFTER THE PROCEDURE AND WAS NOT AVAILABLE FOR AN EVALUATION.). THE GENERATOR 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 UNIT WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE ESU OR THE TRISECT RAPIDE INSTRUMENT.). IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE REPORTED INFORMATION, MOST LIKELY THE THERMAL INSULT TO THE AORTA WAS CAUSED BY INADVERTENT CONTACT BETWEEN THE BRANCHES OF THE TRISECT RAPIDE INSTRUMENT AND THE AORTA. THE USER MANUAL OF THE ESU WARNS THAT BURNS OR FIRES MAY OCCUR DUE TO ACCIDENTALLY ACTIVATING AN INSTRUMENT. ALSO, THE MANUAL WARNS THAT UNWANTED TISSUE TRAUMA CAN OCCUR IF TISSUE COMES INTO CONTRACT WITH A INSTRUMENT THAT IS STILL HOT. THE TRISECT RAPIDE INSTRUMENT NOTES ON USE WARNS THAT TISSUE IN THE JOINT AREA MAY BE THERMALLY DAMAGED WHEN THE INSTRUMENT IS ACTIVATED WITH THE BRANCHES WIDE OPEN AND THAT TISSUE CONTACT WITH THE JOINT AREA OF THE INSTRUMENT SHOULD BE AVOIDED IN THIS CASE. 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) AND AN ERBE TRISECT RAPIDE INSTRUMENT (PART NUMBER 21150-402, LOT NUMBER WO433553.) DURING A TOTAL PELVIC EXENTERATION (TPE) PROCEDURE (NOTE: THE ERBE TRISECT RAPIDE INSTRUMENT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. AND IS NOT DISTRIBUTED IN THE U.S.). NO INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORIES USED IN THE OPERATION. ALSO, THE ESU SETTINGS EMPLOYED WERE NOT CONVEYED TO ERBE. DURING THE POSTOPERATIVE PERIOD, A DELAYED PERFORATION OF THE AORTA WAS DISCOVERED WHICH RESULTED IN MASSIVE BLEEDING AND THE PATIENT DIED (NOTE: IT APPEARS THAT A THERMAL LESION ON THE AORTA OCCURRED DURING THE TPE PROCEDURE WHILE USING THE ERBE TRISECT RAPIDE INSTRUMENT.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938963 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Death