BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 12557263 · Received September 30, 2021

    Report

    Report Number
    1717344-2021-01334
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 30, 2021
    Manufacturer
    NEW DEANTRONICS LTD
    Product Code
    GEI
    UDI-DI
    10884521767805
    PMA / PMN Number
    K183594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD INSUFFICIENT ADHESION. INSULATION SHEATH CAME OFF FROM THE POINT OF USE. ANOTHER DEVICE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452006 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI NEW DEANTRONICS LTD E3781R-28ASP 10884521767805

    Patients

    Seq Age Sex Outcome Treatment
    1