BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC ELECTRODE PTFE COATED WIRE L-HOOK

    MDR report key: 8740465 · Received June 27, 2019

    Report

    Report Number
    3007728276-2019-00001
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    November 29, 2018
    Report Date
    June 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE SEAL IS DIFFICULT TO REMOVE AND RESULTS IN TEARING OF THE POUCH WHEN ATTEMPTING TO OPEN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531737 LAPAROSCOPIC ELECTRODE PTFE COATED WIRE L-HOOK ELECTROSURGICAL ELECTRODE GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD 1806045

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly