BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21G HOFFMAN/AHMED HORIZONTAL SCISSOR

    MDR report key: 4268543 · Received November 4, 2014

    Report

    Report Number
    3019924-2014-00050
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 30, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH CORROSION AND PITTING AT THE SITE OF THE FRACTURE WHICH INDICATES THE DEVICE WAS NOT CLEANED AND MAINTAINED ADEQUATELY.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT WHILE USING A HOFFMAN/AHMED HORIZONTAL SCISSORS TO CUT IRIS TISSUE THE SCISSOR BLADE BROKE. THE BROKEN PIECE WAS REMOVED FROM THE EYE AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706672 21G HOFFMAN/AHMED HORIZONTAL SCISSOR OPTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0005 049444

    Patients

    Seq Age Sex Outcome Treatment
    1