BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ KOCH STOP AND CHOP MANIPULATOR

    MDR report key: 4253412 · Received November 12, 2014

    Report

    Report Number
    1920664-2014-00220
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS VISUALLY INSPECTED UNDER A MICROSCOPE, AND COMPARED TO THE MASTER MODEL. THERE WAS NO EVIDENCE OF MATERIAL DEFECT OR MFR ERROR. THE INSTRUMENT BROKE AT 90 DEGREE ANGLE. THE 45 DEGREE ANGLE WAS ALSO BENT SLIGHTLY. THE BEND/BOW IN THE INSTRUMENT IS NOT IN THE DESIGN; THEREFORE IT MAY INDICATE PRESSURE WAS PLACED ON THE DISTAL TIP OF THE INSTRUMENT CAUSING IT TO BREAK.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING SURGERY THE INSTRUMENT BROKE IN THE PTS EYE. THE SURGEON WAS ABLE TO REMOVE THE PARTICLE FROM THE PTS EYE. ADD'L INFO WAS OBTAINED, THE SURGEON REMOVED THE PARTICLE WITH PROVISC WITH NO ADD'L MEDICAL INTERVENTION. THE PT RECOVERED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729534 STORZ KOCH STOP AND CHOP MANIPULATOR KOCH STOP AND CHOP MANIPULATOR HNR BAUSCH & LOMB, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1