BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITLENG PROBE S1.1460U

    MDR report key: 2115423 · Received June 1, 2011

    Report

    Report Number
    MW5020861
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 1, 2011
    Manufacturer
    FCI OPHTHALMICS
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF PROBE BROKE OFF AND DISCOVERED MISSING IMMEDIATELY BY SURGEON UPON REMOVAL FROM RIGHT LACRIMAL DUCT OF (B)(6) MALE WITH RIGHT EYE NASOLACRIMAL DUCT OBSTRUCTION. WHILE THE ENT SURGEON WAS PROBING THE RIGHT LACRIMAL DUCT WITH THE INTENTION OF UNBLOCKING THE DUCT AND PLACING A STENT, THE TIP OF THE PROBE BROKE OFF. THIS WAS DISCOVERED WHEN THE PROBE WAS WITHDRAWN BY THE SURGEON. AN X-RAY WAS TAKEN WHICH CONFIRMED THE PRESENCE OF A BROKEN TIP. DECISION WAS MADE TO ABORT THE PROCEDURE AND THE PT WAS SENT TO A SPECIALIST AT AN EYE CLINIC AND EVENTUALLY HAD THE PIECE REMOVED. PROBE IS RITLENG PROBE S1.(B)(4) -MFR FCI OPHTHALMICS-. DATES OF USE: (B)(6) 2001 -- (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITLENG PROBE S1.1460U RITLENG PROBE HNL FCI OPHTHALMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Disability