BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1791262 · Received August 6, 2010

    Report

    Report Number
    2523835-2010-00083
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 8, 2010
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): ¿NO IMPACT REPORTED¿ (NO CONSEQUENCES TO PT). PRODUCT PROBLEM(S): ¿KNIFE WAS DULL¿ (DULL). THE CUSTOMER REPORTED THE KNIFE WAS DULL. HAD TO OPEN ANOTHER KNIFE TO COMPLETE SURGERY. NO PT IMPACT WAS REPORTED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982865 740790M

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR