BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC ELECTRODE

    MDR report key: 7213627 · Received January 23, 2018

    Report

    Report Number
    3007728276-2018-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    December 25, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO. LTD.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ELECTRODE WAS SET UP AND PUT INTO THE PATIENT'S BODY. IMMEDIATELY WHEN IT WAS USED, IT BECAMED CHARRED AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57853 LAPAROSCOPIC ELECTRODE LAPAROSCOPIC ELECTRODE GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO. LTD. 1612097

    Patients

    Seq Age Sex Outcome Treatment
    1