BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUXTEC

    MDR report key: 2477878 · Received January 29, 2012

    Report

    Report Number
    2477878
    Event Type
    Malfunction
    Date Received
    January 29, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 29, 2012
    Manufacturer
    INTEGRA YORK PA INC.
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON STATED THAT THE LUXTEC LIGHT CORD USED IN CONJUNCTION WITH THE RIGID SHORT STORZ SCOPE, SPM #510599-1 MELTED THE HUB WHEN USED ON THE MEDTRONIC 13CM NEUROENDOSCOPE 2233-005 AND TWO OF THE MEDTRONIC 15.5 CM NEUROPENS 2120-025. THIS WAS DONE PREVIOUS TO THIS NURSE ARRIVING IN THE OR. SURGEON STATED THE LUXTEC CORD IS WHAT THEY USUALLY USE FOR THESE CASES BUT THAT IT WAS NOT COMPATIBLE WITH THE STORZ LIGHT SOURCE IN THE OR. SURGEON STATED THERE WAS NO INJURY TO THE PATIENT, BUT THE CASE WAS PROLONGED APPROXIMATELY 30-40 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXTEC LIGHT SOURCE, FIBER OPTIC EQH INTEGRA YORK PA INC. * 0307
    2 NEUROPEN NEUROENDOSCOPE GWG MEDTRONIC NEUROSURGERY * D12639; 2013-08
    3 CHANNEL NEUROENDOSCOPE CHANNEL NEUROENDOSCOPE, HIGH RESOLUTION GWG MEDTRONIC NEUROSURGERY 2233-005 C56933

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR