BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER

    MDR report key: 17400442 · Received July 26, 2023

    Report

    Report Number
    0001932402-2023-70003
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 19, 2023
    Manufacturer
    SYNERGETICS
    Product Code
    GZX
    UDI-DI
    20841305108848
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RECEIVED FOR EVALUATION OPEN IN ITS ORIGINAL POUCH. THE TIP PROTECTOR WAS ON THE END OF THE HANDLE. THE TUBE AND INTERNAL CARBIDE ROD THAT MAKE UP THE SHAFT HAD BROKEN OFF APPROXIMATELY 2MM FROM THE HANDLE AND WAS TAPED TO A YELLOW PIECE OF PAPER. THE TUBE AT THE POINT OF THE BREAK APPEARED STRETCHED AND TORN. THE CARBIDE IS CLEANLY BROKEN. THE PROBE APPEARS TO HAVE BEEN EXPOSED TO RADIAL STRESSES THAT EXCEEDED THE STRENGTH OF THE SHAFT. INFORMATION SUPPLIED BY USER CONFIRMED, DEVICE WAS USED WITH A VALVED CANNULA. INSTRUCTIONS FOR USE WARNINGS STATE, ONLY RETRACTABLE DDMS PRODUCTS ARE COMPATIBLE WITH VALVED CANNULAS. MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE DIAMOND DUSTED MEMBRANE SCRAPER BROKE OFF AT THE HUB INTO THE BACK OF THE PATIENT''S EYE AND INJURED THE RETINA (AFTER IT BROKE OFF OF HANDLE) CAUSING MICROSCOPIC TEARING. THE SURGEON REMOVED THE TIP FROM THE EYE, AND LASERED THE BACK OF THE EYE WHERE THE DIAMOND DUSTED TIP HIT. THE SURGERY WAS PROLONGED AN ADDITIONAL THREE MINUTES. THE PATIENT IS DOING WELL AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840715 STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER INSTRUMENT, MICROSURGICAL GZX SYNERGETICS 20.04.25S M0043153 20841305108848

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STELLARIS UNIT AND ACCESSORIES