BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 30° AUTOCLAVABLE ARTHROSCOPE

    MDR report key: 3092022 · Received May 3, 2013

    Report

    Report Number
    0002936485-2013-00194
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. AN EYE LOUPE AND CAMERA WERE USED TO DETERMINE THE SCOPE HAS METAL SHAVINGS MISSING FROM DISTAL TIP. THE UNIT WAS EVALUATED BY EYE, WITH EYE LOUPE, AND UNDER MICROSCOPE. THE DISTAL TIP HAS SEVERE DENTS AND FIBER DAMAGE. THE DAMAGE IS SEVERE ENOUGH TO ALLOW MOISTURE INTO THE SCOPE WHEN STERILIZED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE DAMAGE HAD OCCURRED DURING USE/HANDLING BY THE CUSTOMER. IN SUM, 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 END OF THE DEVICE WAS SHAVED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF THE DEVICE WAS SHAVED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194752 4.0MM 30° AUTOCLAVABLE ARTHROSCOPE ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1