BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 21959587 · Received May 5, 2025

    Report

    Report Number
    9610614-2025-00022
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BMET AT THE HOSPITAL TESTED THE ESU AND FOUND THAT IT WAS/IS FUNCTIONING WITH SPECIFICATIONS. THEREFORE, THE GENERATOR WAS NOT RETURNED TO ERBE FOR AN EVALUATION. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO PROBLEM WAS FOUND WITH THE ESU THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE MANY POSSIBLE FACTORS WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THEREFORE, A CONCLUSIVE DETERMINATION COULD NOT BE MADE AS TO THE CAUSE(S) OF THE EVENT. NEVERTHELESS, ADDITIONAL IN-SERVICE TRAINING WAS PERFORMED BY OUR ERBE REPRESENTATIVE WITH THE INVOLVED STAFF. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS EVENT. 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) TO PERFORM AN ENDOSCOPIC MUCOSAL RESECTION (EMR). THE ESU WAS USED WITH AN ERBE MONOPOLAR CABLE AND A COOK MEDICAL DUETTE KIT. THE GENERATOR SETTINGS WERE FORCED COAG MODE AT 25 WATTS. DURING THE PROCEDURE, THE PHYSICIAN BELIEVED THAT THE UNIT'S OUTPUT WAS NOT SUFFICIENT BECAUSE HE DIDN'T SEE BLANCHING OF THE TISSUE. THEREFORE, THE DOCTOR TAPPED ON THE BLUE PEDAL UNTIL THE RESECTION OF THE TISSUE WAS COMPLETE. DURING OR UPON THE INTERVENTION, THE PATIENT'S DUODENUM WAS PERFORATED. THEREFORE, THE DOCTOR USED AN OVESCO ENDOSCOPY AG FULL THICKNESS RESECTION DEVICE (FTRD) TO CLOSE THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423457 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H