BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC L-HOOK ELECTRODE

    MDR report key: 9530659 · Received December 30, 2019

    Report

    Report Number
    3007728276-2019-00003
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    January 23, 2019
    Report Date
    December 27, 2019
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD
    Product Code
    GEI
    PMA / PMN Number
    K091672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OPENED THE PRODUCT BOX AND FOUND SEVERAL OF THE STERILE POUCHES HAD HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328492 LAPAROSCOPIC L-HOOK ELECTRODE ELECTROSURGICAL ELECTRODE GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD P0020 1807039

    Patients

    Seq Age Sex Outcome Treatment
    1