BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALUEBLUE PENCIL, RS VB STERILE

    MDR report key: 16276515 · Received February 1, 2023

    Report

    Report Number
    3007216334-2023-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Report Date
    February 1, 2023
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD., IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 130405, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS A VOLUNTARY DISTRIBUTOR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620029 VALUEBLUE PENCIL, RS VB STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ZHEJIANG SHUYOU SURGICAL 2011020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown