BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIS RETRACTORS

    MDR report key: 2923401 · Received December 9, 2010

    Report

    Report Number
    1932402-2010-00001
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), MEDWATCH MFR REPORT NUMBER 9005675-2010-00001. SUMMARY: SYNERGETICS COULD NOT DETERMINE A ROOT CAUSE OF THE REPORTED COMPLAINT. THIS COMPLAINT IS CONSIDERED A MALFUNCTION OF THE DEVICE TO PERFORM ITS INTENDED USE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. CALLS TO THE COMPLAINANT WERE NOT RETURNED TO DETERMINE WHERE THE BREAK OF THE IRIS RETRACTORS OCCURRED. THE IRIS RETRACTORS ARE MADE FROM THE SAME MATERIAL USED TO MFR SUTURES, NYLON, AND COMPLY WITH USP REQUIREMENTS FOR TENSILE STRENGTH WHICH IS DESIGNED TO MINIMIZE ANY BREAKAGE DURING USE. BASED ON THE INFO CONTAINED OR REFERENCED IN THIS REPORT, SYNERGETICS CONSIDERS THIS COMPLAINT TO BE AN ISOLATED OCCURRENCE AND WILL MONITOR THIS COMPLAINT FOR FUTURE CORRECTIVE AND PREVENTIVE ACTION. THIS COMPLAINT WAS CLEARLY A MALFUNCTION IN THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION. HOWEVER, AS THE DEVICE WAS NOT RETURNED AND THE COMPLAINANT COULD NOT BE REACHED TO OBTAIN FURTHER INFO, IT IS UNLIKELY THE MALFUNCTION WOULD HAVE RESULTED IN DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT EXPERIENCE. IF THE IRIS RETRACTOR DID BREAK, THE RETRACTOR SHOULD BE ABLE TO BE REMOVED WITH VITREORETINAL OPHTHALMIC FORCEPS. IT IS UNK WHETHER ANOTHER SET OF IRIS RETRACTORS WERE USED AFTER THE FIRST SET OF IRIS RETRACTORS BROKE AND WHAT WAS THE FINAL RESULT OF THE SURGERY. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    TITLE: (B)(4). EVENT DESC: 2 IRIS RETRACTORS BROKE INSIDE THE EYE WHEN THE SURGEON WAS PUTTING IT IN. HE WAS USING THIS TO OPEN THE PUPIL. THE SURGEON STATES HE WAS ABLE TO RETRIEVE ALL THE BROKEN PIECES. THE SURGEON SPOKE WITH THE MFR ABOUT THIS PRODUCT. DEVICE USAGE PROBLEM. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIS RETRACTORS DISPOSABLE FLEXIBLE IRIS RETRACTOR GZX SYNERGETICS, INC. 40.02-6 9010411

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other