BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 1490175 · Received September 28, 2009

    Report

    Report Number
    2618676-2009-00002
    Event Type
    Other
    Date Received
    September 28, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 22, 2009
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH
    Product Code
    HNN
    PMA / PMN Number
    K822112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON HAD NUMEROUS ISSUES WITH THE 15 DEGREE 3.0MM BLADE (B)(4) ON HIS CATARACT CASES. SEVERAL BLADES HAD TO BE OPENED ON EACH CASE. THERE WERE BURRS ON EACH OF THE BLADES WHEN THEY WERE OPENED FROM THE PACKAGE. NO PT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT 15 DEGREE MICROKNIFE - 3MM HNN SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH 72-1531 M663100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE.