BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON SPONGE

    MDR report key: 16827491 · Received April 27, 2023

    Report

    Report Number
    3011157718-2023-00085
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    November 14, 2018
    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
    WI, 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, THEY FEEL THEIR IMAGING TECHNOLOGY IS GIVING THEM ABNORMALLY LOW RESULTS ON HEAVILY SATURATED LAPS FOR THE LAST 6 WEEKS. THEY HAD A SPONGE TOTAL OF 200 ML'S. AT THE END, THEY THOUGHT SOMEONE FORGOT TO ENTER THE HB BECAUSE THE NUMBER WAS SO LOW SO THEY WENT BACK IN TO START A NEW CASE AND USED THE SAME 25 SPONGES TO IMAGE. THE SECOND TIME THROUGH, OUR TECHNOLOGY TOLD THEM THERE WERE 290ML'S ON THOSE SAME SPONGES. THE CUSTOMER STATED THAT THEY HAD A CASE WHERE THEIR SPONGE QBL GAVE THEM A TOTAL OF 400 ML'S. AFTER WEIGHING THE LAPS ON A BABY SCALE TO COMPARE, THEY HAD NUMBER OF ROUGHLY 1600ML'S. 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, THEY FEEL THEIR IMAGING TECHNOLOGY IS GIVING THEM ABNORMALLY LOW RESULTS ON HEAVILY SATURATED LAPS FOR THE LAST 6 WEEKS. THEY HAD A SPONGE TOTAL OF 200 ML'S. AT THE END, THEY THOUGHT SOMEONE FORGOT TO ENTER THE HB BECAUSE THE NUMBER WAS SO LOW SO THEY WENT BACK IN TO START A NEW CASE AND USED THE SAME 25 SPONGES TO IMAGE. THE SECOND TIME THROUGH, OUR TECHNOLOGY TOLD THEM THERE WERE 290ML'S ON THOSE SAME SPONGES. THE CUSTOMER STATED THAT THEY HAD A CASE WHERE THEIR SPONGE QBL GAVE THEM A TOTAL OF 400 ML'S. AFTER WEIGHING THE LAPS ON A BABY SCALE TO COMPARE, THEY HAD NUMBER OF ROUGHLY 1600ML'S. 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
    489798 TRITON SPONGE 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