BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 200 S

    MDR report key: 16284803 · Received February 2, 2023

    Report

    Report Number
    9610614-2023-00007
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    December 2, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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, THERE ARE NUMEROUS POSSIBLE CAUSES INVOLVED WITH THE EVENT. THE LIKELIHOOD OF THE REPORTED COMPLICATION, UPON AN ECRP PROCEDURE, IS WELL KNOWN. NEVERTHELESS, 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 EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE ESU WAS USED WITH AN OLYMPUS CLEVERCUT SINGLE USE SPHINCTEROTOME AND AN ERBE NESSY OMEGA NEUTRAL ELECTRODE (PART NUMBER: 20193-082, LOT NUMBER: INFORMATION NOT PROVIDED). THE NEUTRAL ELECTRODE WAS PLACED ON THE PATIENT'S LEFT THIGH. THE ESU SETTINGS WERE ENDOCUT I EFFECT 2/3. UPON THE PROCEDURE, THERE WERE NO IMMEDIATE CLINICAL ISSUES. HOWEVER, IN A FOLLOW-UP EXAMINATION (ON (B)(6) 2022); INFLAMMATION, SWELLING, AND NECROSIS OF THE PAPILLA VATERI IN THE DUODENUM WAS OBSERVED. THEREFORE, TO ADDRESS THE ISSUE, A COATED STENT WAS INSERTED INTO THE BILE DUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389377 ERBE VIO 200 S ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 S

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention