BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 4MM X 30° ARTHROSCOPE SPEEDLOCK A/C

    MDR report key: 3854309 · Received June 6, 2014

    Report

    Report Number
    0002936485-2014-00391
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 NOT RETURNED TO STRYKER ENDOSCOPY FOR EVALUATION. HOWEVER, THE UNIT WAS RECEIVED AND EVALUATED AT AN OEM FOR INVESTIGATION. THE REPORTED FAILURE ¿PIECE OF DISTAL TIP MISSING" WAS CONFIRMED BY OEM.VISUAL INSPECTION: SCOPE WAS EVALUATED BY EYE, WITH EYE LOUPE TO DETERMINE THE SCOPE HAS PIECE OF DISTAL TIP MISSING.FUNCTIONAL INSPECTION: THE DISTAL TIP HAS FIBER AND OUTER TUBE DAMAGE. THE FIBER DAMAGE IS SEVERE ENOUGH TO ALLOW MOISTURE INTO THE SCOPE WHEN STERILIZED.ALLEGED PROBLEM CONFIRMED: YES.ACTUAL FAILURE MODE(S): FIBER, OUTER TUBE.ROOT CAUSE(S): DAMAGED DISTAL TIP FIBER AND OUTER TUBE DAMAGE OCCURRED DURING USE / HANDING BY THE CUSTOMER.MANUFACTURER ERROR: NO.FAILED PART/COMPONENT(S): FIBER, OUTER TUBE.IN SUM, THE PRODUCT WAS RECEIVED AND EVALUATED AT AN OEM AND THE REPORTED FAILURE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A PIECE OF DISTAL TIP MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A PIECE OF DISTAL TIP MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332990 HD 4MM X 30° ARTHROSCOPE SPEEDLOCK A/C ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1