BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST SIEBEL CAPSULORHEXIS FORCEPS

    MDR report key: 3810350 · Received April 11, 2014

    Report

    Report Number
    3019924-2014-00012
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MICROSURGICAL TECHNOLOGY, INC.
    Product Code
    HNR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED MISSING THE O-RING THAT PROVIDES TENSION ON THE HANDLE. THE DEVICE WAS NOT ADEQUATELY INSPECTED PRIOR TO USE AS INDICATED IN THE DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    UPON REMOVAL OF A MST CAPSULORHEXIS FORCEPS FROM THE EYE THE HEAD BECAME DISENGAGED FROM THE HANDLE WHILE STILL IN THE EYE. THE SURGEON WAS ABLE TO REATTACH THE FORCEPS HEAD TO THE HANDLE AND REMOVE THE DEVICE FROM THE EYE WITHOUT IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221527 MST SIEBEL CAPSULORHEXIS FORCEPS OPHTHALMIC FORCEPS HNR MICROSURGICAL TECHNOLOGY, INC. DFH-0030 053335

    Patients

    Seq Age Sex Outcome Treatment
    1