BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM 30° C-MOUNT A/C ARTHROSCOPE W/ LIGHTPOST AT 45° ANGLE

    MDR report key: 2942628 · Received February 4, 2013

    Report

    Report Number
    0002936485-2013-00012
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K962075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. HOWEVER, VISUAL INSPECTION WITH AN EYE LOUPE WAS USED AND IT WAS DETERMINED THE SCOPE HAS A SEPARATED NEEDLE, BROKEN ROD LENSES AND DENTS ON DISTAL TIP AND NEEDLE. WHEN LOOKING THROUGH THE EYEPIECE WITH AN EYE LOUPE, LINES FROM BROKEN ROD LENSES WERE VISIBLE. THE SCOPE SHOWS SIGNS OF USE/HANDLING DAMAGE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED FAILURE MODE COULD NOT BE REPLICATED IN OUR TEST ENVIRONMENT. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION BUT 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 CUSTOMER IS REQUESTING THE UNIT TO BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER IS REQUESTING THE UNIT TO BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47081 2.7MM 30° C-MOUNT A/C ARTHROSCOPE W/ LIGHTPOST AT 45° ANGLE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1