BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGHT ARC ON LAPTOP

    MDR report key: 2313480 · Received October 14, 2011

    Report

    Report Number
    1222895-2011-00028
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 20, 2011
    Report Date
    October 14, 2011
    Manufacturer
    INTEGRA, BURLINGTON
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE NEUROSIGHT ARC (ST1000) WAS USED WITH THE CRW PRECISION ARC SYSTEM (CRWPRECISE) FOR A STEREOTACTIC GUIDED DEPTH ELECTRODE PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE PLANNED SLIDE SETTING OF -56.9 COULD NOT BE SET ON THE CRWPRECISE. THE CRWPRECISE USED HAD A RANGE OF +/-55 FOR THE SLIDE SETTING, WHICH WAS A SMALLER RANGE THAN THE PREDECESSOR CRW ARC SYSTEM. THE NEUROSIGHT ARC DID NOT DIFFERENTIATE WHICH CRW ARC SYSTEM WAS BEING USED. THERE WAS ABOUT A 20 MINUTE DELAY IN SURGERY. THE MODIFICATION DONE TO RESOLVE THE PROBLEM WAS DESCRIBED AS "SCALE MEASUREMENT OF DEGREE INCREMENT SPACING THAT WAS THEN ADDED TO THE PROBE CARRIER POSITION ON THE ARC SLIDE". THERE WAS NO INJURY TO THE PT. CROSS REFERENCE TO MFR REPORT NUMBER: 1222895-2011-00027 (SAME PT, SAME PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGHT ARC ON LAPTOP NA HAW INTEGRA, BURLINGTON

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR