BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 20305511 · Received September 25, 2024

    Report

    Report Number
    3015967359-2024-01840
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 21, 2024
    Report Date
    July 7, 2025
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    UDI-DI
    00859506006029
    PMA / PMN Number
    K163507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: D9, H3, H6. CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE LOG FILES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    DURING A PROCEDURE WITH HEMORRHAGING, THE QUANTITATIVE BLOOD LOSS WAS SIGNIFICANTLY LOWER THAN THE ESTIMATED BLOOD LOSS ON THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264143 TRITON CANISTER IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 00859506006029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown