BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPARSCOPIC ELECTRODE PTFE COATED WIRE L-HOOK

    MDR report key: 7882308 · Received September 17, 2018

    Report

    Report Number
    3007728276-2018-00006
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 17, 2018
    Report Date
    September 17, 2018
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALL SIX ELECTRODES INSIDE THE BOX WERE DISCOVERED TO CONTAIN A HOLE IN THEIR STERILE POUCH. THE HOLE WAS IN THE SAME LOCATION FOR EACH OF THE SIX POUCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720973 LAPARSCOPIC ELECTRODE PTFE COATED WIRE L-HOOK ELECTROSURGICAL ELECTRODE GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD P0100 1709029

    Patients

    Seq Age Sex Outcome Treatment
    1