BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON CANISTER

    MDR report key: 16827192 · Received April 27, 2023

    Report

    Report Number
    3011157718-2023-00139
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 29, 2020
    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
    OR, 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, DURING A PROCEDURE THE QBL BY 190ML FROM ONE SCAN OF CANISTER TO ANOTHER SCAN OF SAME CANISTER. CANISTER WAS AGITATED PRIOR TO EACH SCAN DONE DURING PROCEDURE. SCANNING WAS DONE 4-5 TIMES DUE TO CONCERN OF EXCESS BLOOD LOSS. QBL WENT FROM 936 TO 746. THE CANISTER WAS AGAIN AGITATED AND THE QBL WENT BACK UP TO APPROX. 936. THERE HAD BEEN 200ML OF ADDITIONAL VOLUME ADDED TO CANISTER BETWEEN THE 936 TO 746 SCAN. 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, DURING A PROCEDURE THE QBL BY 190ML FROM ONE SCAN OF CANISTER TO ANOTHER SCAN OF SAME CANISTER. CANISTER WAS AGITATED PRIOR TO EACH SCAN DONE DURING PROCEDURE. SCANNING WAS DONE 4-5 TIMES DUE TO CONCERN OF EXCESS BLOOD LOSS. QBL WENT FROM 936 TO 746. THE CANISTER WAS AGAIN AGITATED AND THE QBL WENT BACK UP TO APPROX. 936. THERE HAD BEEN 200ML OF ADDITIONAL VOLUME ADDED TO CANISTER BETWEEN THE 936 TO 746 SCAN. 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
    465070 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