BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIS SCISSORS

    MDR report key: 3973046 · Received April 29, 2014

    Report

    Report Number
    1056591-2014-00032
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE DID NOT CAUSE ANY PROCEDURAL DELAYS, NOR HAVE CAUSED OR CONTRIBUTED TO AN INJURY OR ILLNESS NECESSITATING MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. NO ADVERSE EVENT WERE REPORTED.

    Description of Event or Problem · 1

    DURING SURGEON'S USE OF SCISSORS FOR FASCIA GRAFT PURPOSES, THE SCISSORS TIP BROKE OFF. SURGEON WAS ABLE TO RETRIEVE THE MISSING PIECE WHILE NOT COMPROMISING PATIENT'S SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255544 IRIS SCISSORS IRIS SCISSORS FSM MEDTRONIC 3741132

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR