BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 1708039 · Received May 26, 2010

    Report

    Report Number
    2618676-2010-00001
    Event Type
    Other
    Date Received
    May 26, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH
    Product Code
    HNN
    PMA / PMN Number
    K822112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE DEVICE WAS RECEIVED ON (B)(4) 2010. DEVICE EVAL IS IN PROCESS AS OF THE DATE OR THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCIDENT WITH BLADE 72-1501, LOT M305620. "THE TIP OF THE KNIFE IS TWISTED AND DAMAGED THE PACKAGE (THE STERILITY IS NOT ANY MORE GUARANTEED)." THE CONDITION WAS CAPTURED BEFORE THE OPENING OF THE PACKAGE. THE PRODUCT WAS NOT USED ON PATIENTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT 15 DEGREE MICROKNIFE HNN SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH 72-1501 M305620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other NONE MADE AVAILABLE