BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A'SCOPE, A'CLAVE, HD, 4MM X 70°

    MDR report key: 6002632 · Received October 6, 2016

    Report

    Report Number
    3003604053-2016-00102
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION WAS PERFORMED AND SHOWED THE SCOPE HAS BEEN USED IN THE FIELD. THE SCOPE HAS SEVERE DISTAL TIP AND FIBER DAMAGE. THE SCOPE IS ALSO DENTED WITH INTERNAL CRACKED LENSES. THESE DEFICIENCIES ARE CAUSED BY CONTACT WITH ANOTHER SOURCE. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED. USE ERROR MOST LIKELY CONTRIBUTED TO THE DEVICE CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO COMMENCING AN ARTHROSCOPY PROCEDURE, THE HEALTHCARE PROFESSIONAL NOTED THAT A DENT WAS IN THE SIDE OF THE SCOPE WHICH MADE THE HEALTHCARE PROFESSIONAL CHANGE TO A DIFFERENT SCOPE. A LARGE LABRAL TEAR WAS IDENTIFIED WHILE USING THE BACK-UP DEVICE, THE SURGEON OPTED TO ABANDONED THE PROCEDURE. NO REPORTED PATIENT INJURIES. NO OTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661328 A'SCOPE, A'CLAVE, HD, 4MM X 70° ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. BBK 1065674

    Patients

    Seq Age Sex Outcome Treatment
    1