BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRO SURGICAL INSTRUMENT

    MDR report key: 1709381 · Received September 2, 2009

    Report

    Report Number
    1315756-2009-00004
    Event Type
    Other
    Date Received
    September 2, 2009
    Date of Event
    March 23, 2009
    Report Date
    August 31, 2009
    Manufacturer
    ELECTRO SURGICAL INSTRUMENT CO
    Product Code
    FDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORTER THE LIGHTSOURCE DID NOT MALFUNCTION DURING THE EVENT. ALL INSTRUMENTS LIGHTSOURCE, CABLE AND RETRACTOR WERE CONNECTED AT THE TIME OF THE EVENT AND WERE REMOVED FROM SERVICE TEMPORARILY. OUR RECORDS INDICATE THAT THE RETRACTOR WAS PURCHASED BY THE USER FACILITY AND SHIPPED IN (B)(4) 2002. THERE ARE NO RECORDS OF REPAIRS OR MAINTENANCE TO THIS INSTRUMENT SINCE THAT TIME. INITIAL CONTACT CONFIRMED THAT THE RETRACTOR IS ESI CATALOG NUMBER 08-0186. USER FACILITY REFUSED OUR REQUEST TO SEND THE RETRACTOR FOR EVAL. INITIAL CONTACT PROVIDED SERIAL (B)(4) FOR THE LUXTEC 9300XSP LIGHTSOURCE AND AN UNK FIBEROPTIC CABLE IDENTIFIED ONLY AS CATALOG NUMBER 459ND. USER FACILITY IS AWARE THAT ESI RECOMMENDS USING 150 WATT HALOGEN LIGHT SOURCES WITH OUR PRODUCTS AND SUBSEQUENTLY ORDERED ONE. E-MAIL WAS SENT WITH A HYPERLINK TO OUR CARE AND CLEANING SHEET WHICH INCLUDES DIRECTIONS FOR THE SAFE USE OF INSTRUMENTS WITH HIGH INTENSITY OR XENON LIGHT SOURCES. BELOW IS THE LINK DESCRIBED ABOVE. HTTP://WWW. ELECTROSURGICALINSTRUMENT.COM/ESI%20CARE%20AND%20CLEANING%20INSTRUCTIONS.PDF.

    Description of Event or Problem · 1

    PT WAS BURNED ON THE RIGHT BREAST FROM FIBER OPTIC CONNECTOR WHERE FIBEROPTIC CABLE ATTACHED TO A HARRINGTON BREAST RETRACTOR MODEL 08-0186. LUXTEC MODEL 9300XSP 300 WATT XENON LIGHT SOURCE WAS CONNECTED TO AN UNK BRAND OF FIBEROPTIC CABLE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRO SURGICAL INSTRUMENT FIBEROPTIC RETRACTOR FDG ELECTRO SURGICAL INSTRUMENT CO 08-0186

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other UNK FIBER OPTIC CABLE MODEL 459ND| LUXTEC MODEL 9300 XSP (B)(4)