BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPARSCOPIC ELECTRODE PTFE COATED WIRE L-HOOK

    MDR report key: 8060963 · Received November 12, 2018

    Report

    Report Number
    3007728276-2018-00008
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD
    Product Code
    GEI
    PMA / PMN Number
    K091672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE PACKAGING TEARS WHEN OPENING THE PACKAGE. THE DEVICE IS NO LONGER STERILE IF THE PACKAGE OPENS IMPROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901784 LAPARSCOPIC ELECTRODE PTFE COATED WIRE L-HOOK ELECTROSURGICAL ELECTRODE GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD P0100 1806045

    Patients

    Seq Age Sex Outcome Treatment
    0