BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON 3L CANISTER INSERT KIT

    MDR report key: 19338193 · Received May 16, 2024

    Report

    Report Number
    3015967359-2024-01057
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 18, 2024
    Report Date
    November 12, 2024
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    UDI-DI
    10859506006255
    PMA / PMN Number
    K163507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 WAS NOT AVAILABLE FOR EVALUATION. THE FULL UDI NUMBER IS NOT AVAILABLE DUE TO THE MISSING LOT NUMBER.

    Description of Event or Problem · 0

    PER THE ACCOUNT, DURING A CASE THE DEVICE SHOWED AN ESTIMATED BLOOD LOSS LOWER THAN EXPECTED. THE DEVICE REFLECTED BLOOD LOSS READINGS OF 230ML, 411ML, AND 200ML. THE SURGEON FELT THE BLOOD LOSS SHOULD BE AROUND 800ML. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    PER THE ACCOUNT, DURING A CASE THE DEVICE SHOWED AN ESTIMATED BLOOD LOSS LOWER THAN EXPECTED. THE DEVICE REFLECTED BLOOD LOSS READINGS OF 230ML, 411ML, AND 200ML. THE SURGEON FELT THE BLOOD LOSS SHOULD BE AROUND 800ML. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491222 TRITON 3L CANISTER INSERT KIT IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN 10859506006255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown