BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM

    MDR report key: 21172479 · Received January 16, 2025

    Report

    Report Number
    0002936485-2025-00044
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    August 15, 2024
    Report Date
    April 10, 2025
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K201361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH PRODUCT WAS RETURNED TO STRYKER ENDOSCOPY VIA SERVICE, THE PRODUCT WAS NOT RETURNED TO WOM FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: PATIENT HAD CARDIAC ARREST AFTER START OF THE PNEUMOCLEAR. DIAGNOSTICS: - PERFORM CAL AND USW - REPLACE GAS FILTER AND BATTERY - RESET SERVICE STATE - PERFORM FUNCTIONAL TEST. PROBABLE ROOT CAUSE: BECAUSE DEVICE WAS NOT RETURNED TO OEM - WOM, PROBABLE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT COULD BE NOT CONFIRMED. THERE ARE NO INDICATIONS OF A MANUFACTURING ISSUE. AS PER THE REPORTER, THIS ISSUE OCCURRED IMMEDIATELY AFTER THEY STARTED USING CO2, HENCE THE MOST PROBABLE ROOT CAUSE MIGHT BE: INCORRECT POSITIONING OF INSUFFLATION INSTRUMENT BY THE STAFF, INCLUDING VERESS CANNULA, CAN LEAD TO GAS PENETRATING A VESSEL OR INTERNAL ORGAN AND FINALLY TO GAS EMBOLISM. TO ENSURE PROPER VERESS/TROCAR PLACEMENT DURING THE PROCEDURE, THE PNEUMOCLEAR DEVICE IS SUPPLIED WITH APPROPRIATE WARNINGS. THE DEVICE WORKED AS INTENDED, HENCE A DEVICE MALFUNCTION CAN BE RULED OUT. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. FILLING ON BEHALF OF WORLD OF MEDICINE (WOM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892216 PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other