BEUDAMED
    FDA Adverse Event Death Summary report: N

    PKG, PNEUMO SURE XL HG FLW INSUFFLATOR

    MDR report key: 20972868 · Received December 18, 2024

    Report

    Report Number
    0002936485-2024-00967
    Event Type
    Death
    Date Received
    December 18, 2024
    Date of Event
    July 31, 2024
    Report Date
    March 31, 2025
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    UDI-DI
    07613327063295
    PMA / PMN Number
    K063367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: PATIENT DEATH, NO OTHER INFORMATION WAS GIVEN. THE COMPLAINANT WAS CONTACTED FOR FURTHER EVENT DETAILS AND THE INVOLVEMENT OF THE STRYKER DEVICE. THE COMPLAINANT RESPONDED THAT THERE WERE NO ADDITIONAL EVENT DETAILS AVAILABLE AND THAT WHILE THE STRYKER DEVICE WAS IN USE AT TIME OF THE EVENT, CAUSE OR CONTRIBUTION WAS UNABLE TO BE DETERMINED AT THIS TIME. THE DEVICE WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, THE DEVICE WAS RECEIVED WITH A CALIBRATION STICKER SHOWING CALIBRATION WAS PAST DUE ON (B)(6) 2015. THE QUALITY SEAL IS PARTIALLY TORN. A STICKER FROM A THIRD-PARTY COMPANY WAS PRESENT INDICATING AN INSPECTION WAS DUE ON THE DEVICE IN (B)(6) 2024. THE CHASSIS WAS INSPECTED WITH THE FOLLOWING OBSERVANCES NOTED: THE UNIT WAS RECEIVED WITH A TUBESET ADAPTER. THE SINTER FILTER ON THE GAS ADAPTER APPEARS SATURATED WITH DEBRIS. UPON FUNCTIONAL INSPECTION, THE DEVICE WAS POWERED ON AND SUCCESSFULLY COMPLETED THE SELF CHECK. THE REVIEW OF THE ERROR LOG SHOWED THAT THE SELF TEST ON THE LPU FAILED SEVERAL TIMES. THE LPU SELF CHECK OCCURS WHEN THE DEVICE IS POWERED ON. IF THE SELF TEST FAILS, THE USER CANNOT SELECT AN OPERATING SCREEN AND THE DEVICE WILL NOT FUNCTION UNTIL THE UNIT IS POWER CYCLED AND THE SELF CHECK PASSES. FLOWRATE AND PRESSURE TESTS WERE PREFORMED, THE UNIT PASSED EACH OF THESE TESTS WITH NO OBSERVANCES AND THE DEVICE PERFORMED TO SPECIFICATION. THE INSUFFLATOR WAS THEN RUN WITH A SET PRESSURE OF 10 MM HG, 20 MM HG, AND 30 MM HG WHILE IN VERESS INSUFFLATION. THE OVERPRESSURE ALARM SOUNDED AS INTENDED. THE UNIT WAS POWER CYCLED FOR 20 COMPLETE CYCLES. THERE WERE NO ERRORS OBSERVED. THE SAFETY FUNCTIONS OF THE DEVICE WERE TESTED AND FOUND TO MEET SPECIFICATION WITH NO ERRORS OBSERVED. AS NOTED, THE SINTER FILTER ON THE GAS ADAPTER APPEARED TO BE SATURATED WITH DEBRIS, THIS COULD POSSIBLY AFFECT THE FLOW RATE OF CO2. THIS WOULD MEAN THAT THE TIME TAKEN FOR THE FLOW OF THE INSUFFLATOR TO REACH A SET PRESSURE COULD TAKE LONGER THAN USUAL IF THE SINTER FILTER IS OBSTRUCTED. HOWEVER, THE SAFETY FUNCTIONS OF THE DEVICE WERE TESTED AND FOUND TO MEET SPECIFICATION WITH NO ERRORS OBSERVED. ADDITIONALLY, WHILE ERROR LOGS INDICATED THAT THE LPU HAD FAILED THE SELF TEST, THE DEVICE PASSED ALL FUNCTIONAL CRITERIA AND NO FUNCTIONAL ABNORMALITIES WERE IDENTIFIED. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. AS A SPECIFIC DEFICIENCY OR FAILURE OF THE DEVICE WAS NOT REPORTED BY THE ACCOUNT, THE SPECIFIC EVENT COULD NOT BE CONFIRMED. THE DEVICE WAS OPERATING ACCORDING TO SPECIFICATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT AND THE INVESTIGATION RESULTS OF THE RETURNED DEVICE, IT DOES NOT SEEM LIKELY THAT THE STRYKER DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PATIENT DEATH, NO OTHER INFORMATION WAS GIVEN. MULTIPLE ATTEMPTS FOR FURTHER INFORMATION WERE MADE, HOW NO RESPONSE WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PATIENT DEATH, NO OTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082814 PKG, PNEUMO SURE XL HG FLW INSUFFLATOR INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE 07613327063295

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Death