BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALUEBLUE PENCIL, PB VB STERILE

    MDR report key: 19211738 · Received April 30, 2024

    Report

    Report Number
    1320894-2024-00114
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Report Date
    April 30, 2024
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL
    Product Code
    GEI
    UDI-DI
    06924274955962
    PMA / PMN Number
    K040780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO DATE AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A RISK ANALYSIS CANNOT BE CONDUCTED SINCE CONMED DOES NOT OWN THE RISK DOCUMENTS FOR THIS DEVICE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 THE NAME OF THE DEVICE WAS CORRECTED FROM 138114A TO 130403. THE DEVICE HAS NOT BEEN RETURNED TO DATE AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A RISK ANALYSIS CANNOT BE CONDUCTED SINCE CONMED DOES NOT OWN THE RISK DOCUMENTS FOR THIS DEVICE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138114A, 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.

    Description of Event or Problem · 0

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,130403, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171926 VALUEBLUE PENCIL, PB VB STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ZHEJIANG SHUYOU SURGICAL 2101002 06924274955962

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown