BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30 LITER HIGH FLOW INSUFFLATOR

    MDR report key: 3041559 · Received April 8, 2013

    Report

    Report Number
    0002936485-2013-00127
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN PROBABLY CAUSED BY: PRESSURE SENSOR MALFUNCTION / OUT OF CALIBRATION, SOFTWARE MALFUNCTION, USE ERROR AND/OR INSUFFLATOR OPERATED IN LEAST FAVORABLE ENVIRONMENTAL CONDITIONS FOR AN EXTENDED PERIOD OF TIME. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE CAUSED THE PATIENT TO DEVELOP CREPITUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE CAUSED THE PATIENT TO DEVELOP CREPITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143376 30 LITER HIGH FLOW INSUFFLATOR N/A FCX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1