BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALUEBLUE PENCIL, PB VB STERILE

    MDR report key: 12386798 · Received August 30, 2021

    Report

    Report Number
    1320894-2021-00325
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Report Date
    August 30, 2021
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL
    Product Code
    GEI
    UDI-DI
    06924274955955
    PMA / PMN Number
    K040780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE CUSTOMER'S COMPLAINT OF AN INSUFFICIENT HEAT SEAL LEADING TO A BREACH IN STERILITY HAS CONFIRMED THE REPORTED ISSUE. CONMED RECEIVED TWO 130403 RETURNED UNOPENED IN ORIGINAL PACKAGING. THE LOT NUMBER OF THE DEVICE ¿ 2008080 WAS VERIFIED. A VISUAL INSPECTION FOUND GAPS IN THE SEAL CAUSED BY THE PACKAGING LIFTING. A FUNCTIONAL INSPECTION WAS THEN PERFORMED, AND THE DEVICES WERE DYE LEAK TESTED PER POLICY. THE DYE LEAK TESTING INDICATED THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL ON BOTH RETURNED DEVICES. AN EVALUATION BY THE SUPPLIER ON RESERVED SAMPLES OF THE SAME BATCH FOUND NO ISSUES WITH THE SEAL OF THE PACKAGE. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. THE DEVICE HISTORY RECORD PROVIDED FROM THE SUPPLIER FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A RISK ANALYSIS CANNOT BE CONDUCTED FOR THIS DEVICE SINCE CONMED DOES NOT OWN THE RISK DOCUMENTS FOR THIS DEVICE. CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 130403 LOT 2008080, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280845 VALUEBLUE PENCIL, PB VB STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ZHEJIANG SHUYOU SURGICAL IIIA-D006-SG040 2008080 06924274955955

    Patients

    Seq Age Sex Outcome Treatment
    1