BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G, HOFFMAN/AHMED HORIZONTAL SCISSORS STR.

    MDR report key: 4379102 · Received December 23, 2014

    Report

    Report Number
    3019924-2014-00059
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Report Date
    December 18, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCISSOR WAS RETURNED WITH DAMAGE THAT IS INDICATIVE OF THE SCISSOR BEING USED TO CUT TOO HARD OF AN OBJECT. THE SCISSOR WAS MOST LIKELY DAMAGED IN A PREVIOUS USE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE 23G, HOFFMAN/AHMED HORIZONTAL SCISSOR BROKE WHEN THE SURGEON ATTEMPTING TO CUT TISSUE IN THE EYE. THE BROKEN PIECE OF THE SCISSOR WAS REMOVED AND THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848427 23G, HOFFMAN/AHMED HORIZONTAL SCISSORS STR. OPHTHALMIC SCISSOR HNF MICROSURGICAL TECHNOLOGY, INC. DFH-0010 038538

    Patients

    Seq Age Sex Outcome Treatment
    1