BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGHT INSTRUMENTS, INC.

    MDR report key: 2472782 · Received February 24, 2012

    Report

    Report Number
    1052234-2012-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    July 22, 2011
    Report Date
    February 24, 2012
    Manufacturer
    INSIGHT INSTRUMENTS, INC.
    Product Code
    EPT
    PMA / PMN Number
    E286131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A VITRECTOMY PROCEDURE THE TIP OF THE TORPEDO MINI-LIGHT (B)(4) MELTED AND FORMED A BULB AT THE END. NO PT IMPACT WAS REPORTED. NO INFO AVAILABLE ABOUT SYSTEM USED. NO INFO AVAILABLE ABOUT INCISION MADE OR NOT. NO CONTACT OF PRODUCT WITH PT. EVENT OCCURRED DURING PROCEDURE. "AFFILIATE HAS INDICATED THIS OCCURRED DURING A PROCEDURE, NO HARM TO THE PT, AND IT WAS DETERMINED TO BE A REPORTABLE EVENT." INCONCLUSIVE. VISUAL INSPECTION OF ONE TIME USE DEVICE SHOWS PROBABLE SIGNS OF RE-STERILIZATION, CLEANING, OR REPROCESSING.

    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 M55285

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR