BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM PROBE

    MDR report key: 5002268 · Received August 13, 2015

    Report

    Report Number
    0002936485-2015-00722
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 20, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: EXCESSIVE FORCE APPLIED BY USER, PATIENT ANATOMY, PORTAL LOCATION, INCORRECT INSTRUMENT DIAMETER/LENGTH, MANUFACTURING ERROR, REPROCESSING/HANDLING ERROR, IMPROPER INSTRUMENT SELECTED, LACK OF MAINTENANCE, USE ERROR - ATTEMPTING TO CUT IMPROPER MATERIALS. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT PIECE BROKE OFF; HOWEVER, THE SURGEON WAS ABLE TO RETRIEVE THE PIECE THAT BROKE OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT PIECE BROKE OFF; HOWEVER, THE SURGEON WAS ABLE TO RETRIEVE THE PIECE THAT BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534694 3.0MM PROBE PROBE HXB STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1