BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDONE SURGICAL, INC.

    MDR report key: 4602794 · Received March 9, 2015

    Report

    Report Number
    1064371-2015-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Date of Event
    February 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MEDONE SURGICAL, INC.
    Product Code
    NGY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS REQUESTED FOR OUR INVESTIGATION BUT WAS NOT RETURNED. ALL DEVICES FROM THIS LOT WERE DISTRIBUTED (LAST DATE OF DISTRIBUTION OF THIS LOT WAS 01/14/2015) WITH NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER NOR ANY SIMILAR COMPLAINTS EVER REPORTED FOR THIS PRODUCT NUMBER IN THE PAST TEN YEARS. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    TIP DETACHED FROM CANNULA DURING SURGERY. CANNULA WAS BEING USED FOR FLUID EXTRACTION DURING VITRECTOMY PROCEDURE. DURING THE CASE, THE SURGEON NOTICED THAT THE CLEAR FLEX TIP DETACHED FROM THE CANNULA. SURGEON'S FELLOW WAS ABLE TO GRASP THE FLEX TIP WITH FORCEPS AND ATTEMPTED TO PULL IT OUT THRU 25G CANNULA. FLEX TIP WAS NOT PRESENT ON FORCEPS ONCE OUTSIDE THE EYE. SURGEON PERFORMED ADDITIONAL EXAMINATIONS OF POSTERIOR CHAMBER OF EYE BUT WAS UNABLE TO VISUALIZE THE FLEX TIP AND ABORTED THE SEARCH. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161796 MEDONE SURGICAL, INC. OPHTHALMIC CANNULA NGY MEDONE SURGICAL, INC. J1425

    Patients

    Seq Age Sex Outcome Treatment
    1