BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_ENDOSCOPY_PRODUCT

    MDR report key: 6199955 · Received December 22, 2016

    Report

    Report Number
    0002936485-2016-01207
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    October 2, 2014
    Report Date
    May 8, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: INSUFFLATION PRESSURE WAS TOO HIGH. PROBABLE ROOT CAUSE: PRESSURE SENSOR MALFUNCTION / OUT OF CALIBRATION; SOFTWARE MALFUNCTION; USE ERROR; SYSTEM DESIGN; UNWANTED MOVEMENT OF INTERNAL COMPONENTS / WIRING; INSUFFLATOR OPERATED AT LEAST-FAVORABLE ENVIRONMENTAL CONDITIONS FOR AN EXTENDED PERIOD OF TIME. PRESSURE BUTTON DOES NOT DISENGAGE. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    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. GTIN:UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICAL PROCEDURE WAS CONVERTED TO AN OPEN SURGERY AND RESULTED IN PATIENT DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICAL PROCEDURE WAS CONVERTED TO AN OPEN SURGERY AND RESULTED IN PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847957 UNKNOWN_ENDOSCOPY_PRODUCT UNKNOWN GCQ STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death