BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 200 S

    MDR report key: 16910389 · Received May 11, 2023

    Report

    Report Number
    9610614-2023-00027
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    March 30, 2023
    Report Date
    May 11, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ESU WAS INSPECTED/TESTED. THE UNIT 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 GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE PROVIDED INFORMATION, THE REPORT OF THE PATIENT COMPLAINING OF PAIN DURING THE PROCEDURE WAS MOST LIKELY THE RESULT OF LOW FREQUENCY CURRENTS. THIS IS A KNOWN PHENOMENON IN ELECTROSURGERY AND OCCURS MOSTLY WITH NON-CONTACT MODALITIES OR MODES LIKE ENDOCUT WHERE THERE ARE ALTERNATING CUTTING AND COAGULATION PHASES. A PERFORATION IS A RARE BUT SERIOUS COMPLICATION OF A DIAGNOSTIC ERCP. A THERMAL INJURY (E.G., FROM HF-CURRENT) AND/OR MECHANICAL INJURY (E.G., FROM THE ACCESSORY) CANNOT BE EXCLUDED AS POTENTIAL FACTORS IN THE INCIDENT. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. 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 AND AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE ESU WAS USED WITH A COOK SPHINCTEROTOME (G34779) AND A 3M NEUTRAL ELECTRODE. THE NEUTRAL ELECTRODE WAS PLACED ON THE PATIENT'S RIGHT THIGH. THE ESU MODE ENDOCUT I WAS USED. DURING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN. THE FOLLOWING DAY, THE PATIENT CAME BACK TO THE HOSPITAL WITH PAIN AND A FEVER. A PERFORATION WAS DETECTED AND SURGERY WAS PERFORMED TO ADDRESS THE ISSUE. THE PATIENT WAS THEN IN THE HOSPITAL FOR SEVEN (7) DAYS TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183607 ERBE VIO 200 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 S

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R