BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 20744871 · Received November 21, 2024

    Report

    Report Number
    9610614-2024-00063
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED (NOTE: THE INVOLVED LOOP ELECTRODE WAS DISPOSED OF POSTOPERATIVELY AND IS THEREFORE NO LONGER AVAILABLE FOR AN EXAMINATION.). 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 CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE PROVIDED INFORMATION, THERE ARE MANY POSSIBLE CAUSES FOR THE REPORTED EVENT. MOST LIKELY, THE LOOP ELECTRODE WAS SUBJECTED TO EXCESSIVE MECHANICAL AND/OR ELECTRICAL STRESS DURING THE PROCEDURE AND THEREFORE IT BROKE. ALSO, IT IS POSSIBLE THAT THE REUSABLE ELECTRODE WAS DAMAGED DURING REPROCESSING. PER THE LOOP ELECTRODE'S NOTES ON USE, THE ELECTRODE MUST BE PROTECTED FROM MECHANICAL STRESS AND CHECKED FOR POSSIBLE DAMAGE BEFORE USE. FURTHERMORE, THE DIELECTRIC STRENGTH OF THE INSTRUMENT MUST BE OBSERVED. FINALLY, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE EXACT CAUSE OF THE REPORTED ISSUE. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A HIP TEP. THE ESU WAS USED WITH AN ERBE LOOP ELECTRODE (PART NUMBER: 21191-043, LOT NUMBER: INFORMATION NOT PROVIDED). NO INFORMATION WAS PROVIDED REGARDING ANY OF THE OTHER ACCESSORIES USED IN THE PROCEDURE. ALSO, THE ESU SETTINGS USED WERE NOT PROVIDED. DURING THE RESECTION OF THE JOINT CAPSULE, THE LOOP ELECTRODE BROKE. A SMALL PART OF THE ELECTRODE WAS MISSING AND PRESUMABLY IT IS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460095 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other