BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ENDOSCOPY_PRODUCT

    MDR report key: 4252347 · Received November 14, 2014

    Report

    Report Number
    0002936485-2014-00924
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE AGGRESSIVE MAX SHAVER BLADE WAS VISUALLY INSPECTED FOR DAMAGES, AND THE TIP HAS BROKEN OFF. UNABLE TO PERFORM A FUNCTIONAL INSPECTION DUE TO THE BROKEN TIP. THE PROBABLE ROOT CAUSE COULD BE DESIGN AND/OR EXCESSIVE FORCE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT FELL OFF INTO THE PATIENT AND WAS RETRIEVED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT FELL OFF INTO THE PATIENT AND WAS RETRIEVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738249 UNKNOWN_ENDOSCOPY_PRODUCT UNKNOWN GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1