BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L300 SURGICAL ILLUMINATOR

    MDR report key: 2719410 · Received August 28, 2012

    Report

    Report Number
    1222895-2012-00025
    Event Type
    Malfunction
    Date Received
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA INC.
    Product Code
    FSW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE UNIT WAS INVOLVED IN AN INCIDENT. THE LAMP LITERALLY EXPLODED TAKING OUT THE REFLECTORS. SOME PARTS WERE REPLACED BY BIOMEDICAL DEPARTMENT IN AN ATTEMPT TO REPAIR THE UNIT. ON (B)(4) 2012, BIOMEDICAL DEPT AND SURGICAL EQUIPMENT TECH REPORT NO REAL "EXPLOSION", THE DEVICE SMOKED AND THE DEVICE LAMP AND BOTH REFLECTORS WERE SIGNIFICANTLY DAMAGED. THIS OCCURRED DURING "BACK" SURGERY AND THERE WAS NO HARM TO PT OR STAFF. DEVICE WAS QUICKLY REPLACED AND THERE WAS NO REAL DOWNTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L300 SURGICAL ILLUMINATOR COGENT 270 SURGICAL ILLUMINATOR FSW INTEGRA BURLINGTON, MA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1