BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 20146253 · Received September 5, 2024

    Report

    Report Number
    3015967359-2024-01771
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 6, 2024
    Report Date
    June 17, 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
    MA, 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

    DURING SURGERY, THE DEVICE WOULD NOT TURN ON PROPERLY AND IT STATED OVER FOUR LITERS OF BLOOD LOSS WHEN THE LAPS AND TOWELS WERE NOT IN IT. THE DOCTOR WAS NOTIFIED AND HAD TO ESTIMATE THE TOTAL BLOOD LOSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913096 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