BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 16827439 · Received April 27, 2023

    Report

    Report Number
    3011157718-2023-00171
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    June 27, 2019
    Report Date
    July 21, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    PMA / PMN Number
    K142801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FOR BACKGROUND, STRYKER ACQUIRED GAUSS SURGICAL INC. (¿GAUSS¿) ON SEPTEMBER 1, 2021. THE MAJORITY OF THE LATE MDRS RESULTED FROM A RETROSPECTIVE REVIEW OF REPORTABILITY DECISIONS MADE PRIOR TO THE ACQUISITION. ADDITIONALLY, STRYKER HAS DETERMINED THAT A CAPA IS NEEDED TO IMPROVE THE POST-ACQUISITION COMPLAINT REVIEW PROCESS ¿ AS A RESULT, CAPA #3338129 WAS APPROVED ON JUNE 14, 2023 AND OPENED ON JUNE 19.

    Description of Event or Problem · 0

    PER THE CUSTOMER, "WE ARE QUESTIONING THE ACCURACY OF THE CANISTERS QBL." THE CUSTOMER STATED THAT THEY ARE GETTING READINGS FROM THE SUCTION CANISTERS IN THE OR, LIKE 10CC QBL AND A COUPLE MORE OF <100CC OF QBL. 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 CUSTOMER, "WE ARE QUESTIONING THE ACCURACY OF THE CANISTERS QBL." THE CUSTOMER STATED THAT THEY ARE GETTING READINGS FROM THE SUCTION CANISTERS IN THE OR, LIKE 10CC QBL AND A COUPLE MORE OF <100CC OF QBL. 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
    465076 TRITON CANISTER IMAGE PROCESSING DEVICE FOR ESTIMATION OF EXTERNAL BLOOD LOSS PBZ STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown