BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3038360 · Received April 2, 2013

    Report

    Report Number
    2523835-2013-00042
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 8, 2013
    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
    NO
    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

    A SURGEON REPORTED THAT DURING A PROCEDURE, THE KNIFE WAS NOT AS SHARP AS IT SHOULD BE WHEN MAKING THE INCISION. ANOTHER KNIFE WAS USED AND THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135318 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CLEARCUT BP2 DB SLIT 2.2MM ANG