BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON SPONGE

    MDR report key: 16827191 · Received April 27, 2023

    Report

    Report Number
    3011157718-2023-00083
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    November 7, 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
    NY, 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, TRITON SPONGE GIVING NEGATIVE VALUES. CUSTOMER STATED THAT THE SPONGES IMAGED IN SOME CASES BEING NOT FULLY REPRESENTED IN THE 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, TRITON SPONGE GIVING NEGATIVE VALUES. CUSTOMER STATED THAT THE SPONGES IMAGED IN SOME CASES BEING NOT FULLY REPRESENTED IN THE 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
    465069 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