BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION DSP 25G, CURVED SCISSORS

    MDR report key: 1648722 · Received March 25, 2010

    Report

    Report Number
    3003398873-2010-00003
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 21, 2010
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS VISUALLY INSPECTED. IT WAS FOUND THAT ONE OF THE BLADES OF THE 25GA CURVED SCISSORS IS BROKEN. THE BREAKAGE INDICATES THE PRESENCE OF STRESS CRACK CORROSION. DURING FORMING OF THE INSERTS STRESS CRACKS CAN BE INTRODUCED, IF THE DUCTILITY OF THE MATERIAL IS INSUFFICIENT. SUCH STRESS CRACKS CAN LEAD TO STRESS CRACK CORROSION OVER A LONGER TIME PERIOD. THIS COMPLAINT IS THE FIRST ONE AFTER THE IMPROVEMENT OF THE HARDENING PROCESS. IT IS THE FIRST COMPLAINT AFTER (B)(4) MFG DEVICES. IN FACT, IT IS NOT POSSIBLE TO AVOID SINGLE CASES OF CORROSION DURING THE MFG PROCESSES BECAUSE OF POTENTIAL INHOMOGENEOUS OF THE RAW MATERIAL. THEREFORE, NO CORRECTIVE ACTIONS WILL BE PERFORMED AND THE ISSUE IS REGARDED AS A SINGLE EVENT. (B)(4).

    Description of Event or Problem · 1

    MALFUNCTION: BROKEN SCISSORS. THE SURGEON REPORTED, WHEN THE SCISSORS WERE INSERTED THROUGH THE TROCAR CANNULA INTO THE EYE, THE CROSS ACTION CUTTING WAS NOT OBSERVED. THE SURGEON NOTED UPON EXTRACTION OF THE SCISSORS, ONE OF THE BLADES WAS BROKEN. THERE WAS NO IMPACT TO THE PT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION DSP 25G, CURVED SCISSORS SCISSORS, OPHTHALMIC HNF ALCON GRIESHABER AG 705.52 F73210

    Patients

    Seq Age Sex Outcome Treatment
    1