BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 16582781 · Received March 21, 2023

    Report

    Report Number
    9610614-2023-00018
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 21, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU AND ACCESSORIES WERE RETURNED AND THOROUGHLY INSPECTED/TESTED. THE FINDINGS WERE AS FOLLOWS: ESU: THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. A REVIEW OF THE CHRONOLOGICAL DATA AT THE TIME OF THE INCIDENT DID NOT REVEAL ANY EQUIPMENT PROBLEM. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION 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. ACCESSORIES: THE VIO TWO PEDAL FOOTSWITCH [PART NUMBER (P/N) 20189-305, LOT NUMBER (L/N) WO242367], MONOPOLAR CABLE (P/N 20192-130, L/N 0318) AND POWER CABLE (P/N 0322.157L) WERE TESTED AND FOUND TO BE FUNCTIONING PROPERLY. IN CONCLUSION, NO EQUIPMENT OR ACCESSORY PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. THEREFORE, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WILL BE OFFERED TO THE STAFF AT THE MEDICAL CENTER. 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) AND A BOSTON SNARE DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR). THE GENERATOR SETTINGS WERE ENDOCUT Q, EFFECT 3, DURATION 2, INTERVAL 3 AND FORCED COAG, EFFECT 2, 25 WATTS. UPON REMOVING A POLYP IN THE DESCENDING COLON THERE WAS A SIGNIFICANT BURN AT THE SITE OF THE INTERVENTIONAL WORK. THE PATIENT HAD TO BE RE-SCOPED AND CLIPS WERE APPLIED TO THE AFFECTED AREA TO ADDRESS THE NECROSIS. NO FURTHER INFORMATION INVOLVING THE PATIENT'S CONDITION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8967 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention