BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM 30° AUTOCLAVABLE STUBBY ARTHROSCOPE W/ SPEEDLOCK

    MDR report key: 3951535 · Received July 23, 2014

    Report

    Report Number
    0002936485-2014-00514
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS SCOPE WAS RECEIVED AND EVALUATED AT AN OEM FOR INVESTIGATION. THE REPORTED FAILURE ¿PIECE OF DISTAL TIP MISSING" WAS CONFIRMED. PER 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 RETURNED AND THE FAILURE MODE WAS CONFIRMED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431388 2.7MM 30° AUTOCLAVABLE STUBBY ARTHROSCOPE W/ SPEEDLOCK ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1