BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21G HOFFMAN/AHMED HORIZONTAL SCISSOR

    MDR report key: 3899023 · Received May 20, 2014

    Report

    Report Number
    3019924-2014-00016
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 27, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCISSOR WAS RETURNED DIRTY, CORRODED AND RUSTED AT THE SITE OF THE BREAK.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE HOFFMAN/AHMED HORIZONTAL SCISSOR BROKE WHILE BEING USED DURING CATARACT SURGERY. THERE WAS NO REPORTED IMPACT TO THE PATIENT AND THE BROKEN PIECE WAS REMOVED FROM THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299163 21G HOFFMAN/AHMED HORIZONTAL SCISSOR OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY INC. DHF-0005 019734

    Patients

    Seq Age Sex Outcome Treatment
    1