BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G HOFFMAN/AHMED MCRO-SCIS, ST SFT

    MDR report key: 2758062 · Received September 20, 2012

    Report

    Report Number
    3019924-2012-00036
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 14, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON USED A 23 GAUGE MICROSCISSOR OFFLABEL TO CUT AN IOL. THIS MICROSCISSOR IS NOT INTENDED TO CUT HARD OBJECTS SUCH AS IOLS WHICH RESULTED IN THE MALFUNCTION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHILE USING A MICROSCISSOR TO CUT AN IOL THE BLADES BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 23G HOFFMAN/AHMED MCRO-SCIS, ST SFT OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0010 045768

    Patients

    Seq Age Sex Outcome Treatment
    1 Other