BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C

    MDR report key: 4090663 · Received September 15, 2014

    Report

    Report Number
    0002936485-2014-00722
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RECEIVED AND EVALUATED BY THE OEM AND THE FAILURE MODE WAS CONFIRMED. ACCORDING TO (B)(6): 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. BASED ON THE (B)(6) SERVICE REPORT, THE REPORTED FAILURE "PIECE OF DISTAL TIP MISSING" WAS CONFIRMED. ACCORDING TO (B)(6): 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 BY THE (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP IS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569992 HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1