BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUXTEC

    MDR report key: 1015096 · Received March 19, 2008

    Report

    Report Number
    1221336-2008-00001
    Event Type
    Other
    Date Received
    March 19, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 19, 2008
    Manufacturer
    INTEGRA LUXTEC, INC.
    Product Code
    EQH
    PMA / PMN Number
    K864387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED A PT BURN WHILE USING A BREAST RETRACTOR WITH A FIBER OPTIC CABLE (LIGHT GUIDE). THE MANUFACTURER OF THE BREAST RETRACTOR (CUSTOMER - CARDINAL HEATH) RECOMMENDS USE OF A 3.5 MM CABLE TO ENSURE THE CABLE FITS WELL TO THE RETRACTOR. THEIR CUSTOMER CHOSE TO USE A 5.0 MM CABLE. WHEN USING AN OVERSIZED CABLE LIGHT WILL ESCAPE FROM THE RETRACTOR CONNECTION AND CAUSE THE CABLE ENDTIP TO GET HOT. IF THE CABLE IS THEN LAID ON THE PT, THERE IS A POTENTIAL FOR THE PT TO BE BURNED - CARDINAL HEALTH WARNS AGAINST THIS IN THEIR RETRACTOR IFU. BASED ON THE DESCRIPTION OF THE EVENT PROVIDED BY THE USER; ADD'L INFO GATHERED BY OUR OEM CUSTOMER; AND, THE FACT THAT OUR OEM CUSTOMER EXAMINED THE CABLE AND FOUND NO INDICATION OF DAMAGE, WE BELIEVE THE USER LAID THE HOT CABLE AGAINST THE PT AND A BURN RESULTED. THE CABLE PERFORMED PROPERLY, UNFORTUNATELY SOMEONE CHOSE TO USE AN OVERSIZED CABLE AND THEN LAID THE HOT CABLE AGAINST THE PT AND THIS LED TO THE BURNS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUXTEC LIGHT GUIDE OR CABLE EQH INTEGRA LUXTEC, INC. 88-9727

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization