BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK CUTTING FORCEPS, 5MM, 33CM

    MDR report key: 15366353 · Received September 6, 2022

    Report

    Report Number
    3005975494-2022-00038
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 4, 2022
    Report Date
    November 14, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    UDI-DI
    00821925035867
    PMA / PMN Number
    K142759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THE FOLLOWING MEDWATCH REPORTS ARE RELATED: PATIENT IDENTIFIERS (B)(6) (PK-CF0533) AND (B)(6) (PK-CF0533, THIS COMPLAINT).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. AS NO DEVICE WAS RETURNED, A PHYSICAL DEVICE INSPECTION COULD NOT BE PERFORMED. THE OBSERVED FAILURE IS A KNOWN PHENOMENON LIKELY RESULTING FROM INSUFFICIENT GENERATOR OUTPUT NOT PROVING THE USER WITH INTENDED LEVELS OF ENERGY. ON PAGE 3 OF THE DEVICE'S INSTRUCTIONS FOR USE (IFU) (P9100528-001_AD), IT STATES: " WARNING: INSUFFICIENT GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY NOT PROVIDE THE OPERATOR WITH THE DESIRED LEVEL OF COAGULATION." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, WHEN ACTIVATING THE PK CUTTING FORCEPS, 5MM, 33CM NO ENERGY CAME OUT OF THE TIP OF THE JAW ONTO THE TISSUE AND THE GENERATOR DID NOT SOUND AN ERROR CODE. A SECOND PK FORCEPS WAS OPENED WITH THE SAME LOT NUMBER AND THE SAME ISSUE HAPPENED. A THIRD PK FORCEPS WITH THE SAME LOT NUMBER WAS OPENED, WORKED PERFECTLY FINE AND THE CASE CONTINUED WITHOUT ANY FURTHER INTERRUPTIONS. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432205 PK CUTTING FORCEPS, 5MM, 33CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC. PK-CF0533 FR179176 00821925035867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR, SN UNKNOWN