BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM

    MDR report key: 22545757 · Received July 18, 2025

    Report

    Report Number
    0002936485-2025-00650
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 1, 2025
    Report Date
    October 3, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS RECEIVED AT OEM-WOM FOR EVALUATION. BASED ON THE OEM-WOM INVESTIGATION REPORT THE REPORTED FAILURE "PATIENT HEART STOPPED WHILE DOING SURGERY" WAS NOT CONFIRMED. ACCORDING TO WOM: VISUAL INSPECTION: THE DEVICE WAS RECEIVED ON AUG 13, 2025, FOR EVALUATION. THERE ARE NO SIGNS OF TRANSPORT DAMAGE OR MISUSE. UNIT WAS SHIPPED WITH THE CORRECT PACKAGING (PACKAGING DAMAGED), DEVICE IN GOOD COSMETIC CONDITION, HOWEVER THE FILTER HOLDER IS MISSING. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION INDICATED THE RETURNED DEVICE PASSED ALL CRITERIA. THIS INCLUDED AN OCCLUSION, OVERPRESSURE, VENTING VALVE, PRESSURE AND FLOW TEST WITH A RESULT OF PASS. DIMENSIONAL INSPECTION: DUE TO THE NATURE OF THE REPORTED EVENT, THE DIMENSIONAL INSPECTION WAS DEEMED UNNECESSARY AND THEREFORE NOT PERFORMED. INVESTIGATION CONCLUSION: THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE RETURNED PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR, CATALOG#5081198, SN (B)(6) IS WORKING ACCORDING TO SPECIFICATION. PROBABLE ROOT CAUSE: THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND FULL FUNCTIONAL TESTING WAS CONDUCTED. THE DEVICE WAS FOUND TO BE WORKING AS PER SPECIFICATIONS. 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'S HEART STOPPED WITH DURING SURGERY. THE PATIENT MADE IT THROUGH THE SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S HEART STOPPED WITH DURING SURGERY. THE PATIENT MADE IT THROUGH THE SURGERY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231647 PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other