BEUDAMED
    FDA Adverse Event Death Summary report: N

    PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1)

    MDR report key: 6679749 · Received June 29, 2017

    Report

    Report Number
    0002936485-2017-00627
    Event Type
    Death
    Date Received
    June 29, 2017
    Date of Event
    June 8, 2017
    Report Date
    February 15, 2018
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K063367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. (B)(4) STRYKER AHTO TUBE SET WITH TIP PACKAGING (B)(4); (B)(4) PKG., AHTO IRRIGATION PUMP (B)(4); 0620040611 PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1) (B)(4); (B)(4) TUBE SET DISPO WITH HEATING (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALLEGED FAILURE: PROBLEMS WITH THE PATIENT CAME UP DURING SURGERY. THE POWER OF THE INSUFFLATOR HAS BEEN REDUCED IMMEDIATELY AND AT THE END SHUT DOWN. PATIENT COULD NOT BE RESUSCITATED. THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSE/S IN REGARDS TO THE GAS CONNECTOR COULD BE THAT IT WAS NOT PROPERLY CONNECTED AND/OR IT WAS DAMAGED DURING SHIPPING. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WAS NOT CONFIRMED AND WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    FILE FOR PATIENT DEATH DURING MEDICAL PROCEDURE.

    Description of Event or Problem · 1

    FILE FOR PATIENT DEATH DURING MEDICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459299 PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1) INSUFFLATOR, LAPAROSCOPIC HIF STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death