BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 16827063 · Received April 27, 2023

    Report

    Report Number
    3011157718-2023-00044
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 26, 2019
    Report Date
    July 21, 2023
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    PBZ
    PMA / PMN Number
    K163507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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, THE DEVICE WAS INACCURATE. PER THE CUSTOMER, DURING A POST DELIVERY UTERINE ATONY EVENT WITH HEMORRHAGE, GAUSS ESTIMATED THE 1000 VOLUME CANISTER AS 47 ML EBL AND THEN 251 ML WITH 2 READINGS WHEN THE BLOOD LOSS WAS WAY MORE. IT WAS FELT THE PATIENT HAD 200 ML OF AMNIOTIC FLUID AND 800 ML EBL. 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, THE DEVICE WAS INACCURATE. PER THE CUSTOMER, DURING A POST DELIVERY UTERINE ATONY EVENT WITH HEMORRHAGE, GAUSS ESTIMATED THE 1000 VOLUME CANISTER AS 47 ML EBL AND THEN 251 ML WITH 2 READINGS WHEN THE BLOOD LOSS WAS WAY MORE. IT WAS FELT THE PATIENT HAD 200 ML OF AMNIOTIC FLUID AND 800 ML EBL. 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
    1156032 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