BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPSHOOTER HANDLE

    MDR report key: 17339344 · Received July 17, 2023

    Report

    Report Number
    0002936485-2023-00693
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 16, 2023
    Report Date
    June 25, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HXK
    UDI-DI
    07613327375442
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: BLACK DEBRIS ON HANDLE PROBABLE ROOT CAUSE: PROCESS - UNCONTROLLED ENVIRONMENTAL CONDITIONS THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766124 SHARPSHOOTER HANDLE HOLDER, NEEDLE; ORTHOPEDIC HXK STRYKER ENDOSCOPY-SAN JOSE 4700 00022339 07613327375442

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown