BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTIP T I/A TIP SILICONE SLEEVE NEUTRAL .3MM

    MDR report key: 4976718 · Received August 6, 2015

    Report

    Report Number
    3019924-2015-00025
    Event Type
    Injury
    Date Received
    August 6, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MICROSURGICAL TECHNOLOGY INC
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WAS RETURNED FROM THE DISTRIBUTOR CLEAN AND FREE OF ANY SURGICAL RESIDUE OR CONTAMINATES. THERE WAS NORMAL WEAR AND TEAR ON THE DEVICE AS TO BE EXPECTED FROM A DEVICE THAT IS THREE YEARS OLD. THE SOURCE OF THE BLACK SUBSTANCE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING CATARACT SURGERY USING AN INTERTIP T I/A TIP, THE SURGEON NOTICED A BLACK SUBSTANCE INJECTED INTO THE PATIENT'S EYE. THE SURGEON TRIED TO REMOVE THE SUBSTANCE BUT WAS UNSURE IF ALL THE PARTICULATE WAS REMOVED. TWENTY ONE DAYS POST-OP THE PATIENT PRESENTED WITH ENDOPHTHALMITIS AND NEEDED OPERATIVE TREATMENT. THE PATIENTS VISION ACUITY WAS DECREASED FROM 0.7 TO 0.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519687 INTERTIP T I/A TIP SILICONE SLEEVE NEUTRAL .3MM OPHTHALMIC CANNULA HMX MICROSURGICAL TECHNOLOGY INC TT-93307 082212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other