BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15 DEG FRAGMENTATION NEEDLE

    MDR report key: 517571 · Received March 18, 2004

    Report

    Report Number
    517571
    Event Type
    Injury
    Date Received
    March 18, 2004
    Date of Event
    February 26, 2004
    Report Date
    March 1, 2004
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE SURGEON WAS USING THE FRAGMENTOR IN PT'S LEFT EYE WHEN THE TIP BROKE OFF WITHIN THE EYE. A LARGE RETINAL TEAR RESULTED AND IT TOOK TWELVE MINUTES TO RETRIEVE THE TIP. THE RETINAL TEAR HAD TO BE REPAIRED AND THE ORIGINAL SURGICAL PROCEDURE WAS DELAYED. THE SURGEON DOES NOT BELIEVE THIS WILL ADVERSELY AFFECT THE PT'S SURGICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15 DEG FRAGMENTATION NEEDLE FRAGMENTATION NEEDLE HQE BAUSCH & LOMB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention