BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGHT INSTRUMENTS, INC.

    MDR report key: 1742163 · Received June 24, 2010

    Report

    Report Number
    1052234-2010-00001
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    August 28, 2006
    Report Date
    June 21, 2010
    Manufacturer
    INSIGHT INSTRUMENTS, INC.
    Product Code
    EPT
    PMA / PMN Number
    E286131
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INITIAL COMPLAINT INVESTIGATION FOUND FIBER TIP DEFORMATION IDENTICAL TO THAT INVESTIGATED BY INSIGHT ON 02/13/06 AND ALCON ON 02/17/10. IN THAT INVESTIGATION, BOTH THE INSIGHT INVESTIGATION AND THE ALCON RISK MANAGEMENT REPORT IDENTIFIED THAT THE INITIATING CAUSE FOR THE DEVICE FAILURE WAS THE COMBINATION OF THE FIBER TIP BEING OCCLUDED BY BLOOD OR DARK CONTAMINATION WHILE EXPOSED TO AIR IN AN AIR/FLUID EXCHANGE PROCEDURE. THE IDENTIFIED HAZARDS (THERMAL ENERGY AND MECHANICAL DEFORMATION OF THE TIP) WERE THOROUGHLY ANALYZED AND FOUND TO BE ACCEPTABLE (RISK LEVEL A).

    Description of Event or Problem · 1

    TIP OF FIBER OPTIC BURNED AFTER EXTENDED USE AT 100% POWER. PHYSICIAN NEEDED TO ENLARGE SCLEROTOMY TO REMOVE FIBER OPTIC; ADDITIONAL SUTURE REQUIRED. PATIENT OUTCOME REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGHT INSTRUMENTS, INC. MLS TORPEDO MINI-LIGHT EPT INSIGHT INSTRUMENTS, INC. 11007.000 1220105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention