BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYANT ELECTROSURGICAL GENERATOR

    MDR report key: 16502837 · Received March 6, 2023

    Report

    Report Number
    MW5115529
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 3, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RETURN TO THE OPERATING ROOM FOR SMALL BOWEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140935 VOYANT ELECTROSURGICAL GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization