BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFLOW CONSOLE

    MDR report key: 3092639 · Received May 3, 2013

    Report

    Report Number
    0002936485-2013-00200
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K123441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE ANONYMOUS SURVEY WE ARE UNABLE TO IDENTIFY THE SPECIFIC DEVICE INVOLVED IN THE REPORTED EVENT. THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE REPORTED EVENT WAS REPORTED BASED ON AN ANONYMOUS SURVEY FOR USER FEEDBACK FROM A GROUP OF COMPANY REPRESENTATIVE PERSONNEL AS A RESULT OF A LIMITED LAUNCH OF THE DEVICE. HOWEVER, ACCORDING TO THE ANALYSIS PERFORMED BY STRYKER (B)(4), THE REPORTED FAILURE COULD HAVE LIKELY BEEN CAUSED BY: USER ERROR, INFLOW TUBESET CONNECTED TO SALINE BAG PRIOR TO INSERTION INTO PUMP AND/OR SOFTWARE ERROR. IN SUM, THE PRODUCT WAS RETURNED BUT COULD NOT BE IDENTIFIED FOR INVESTIGATION AND THEREFORE, WE COULD NOT CONFIRM THE REPORTED FAILURE MODE. 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 SHOULDER BLEW UP (EXTRAVASATION) DURING THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SHOULDER BLEW UP (EXTRAVASATION) DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194844 CROSSFLOW CONSOLE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1