BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE HEADLIGHT STANDARD 7.5FT

    MDR report key: 1592698 · Received January 28, 2010

    Report

    Report Number
    1221336-2010-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    October 21, 2009
    Report Date
    January 28, 2010
    Manufacturer
    INTEGRA LUXTEC, INC.
    Product Code
    EQH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    OPERATING ROOM MATERIALS MANAGER AND RISK MANAGER REPORTED THAT A PT WAS BURNED (3RD DEGREE BLISTERING, LATER NEEDING DÉBRIDEMENT) ON THE ANTERIOR CHEST WALL DURING A MASTECTOMY ON (B) (6) 2010. THEY ARE NOT SURE WHICH INSTRUMENTS/CABLES WERE IN USE DURING THE SURGERY. POSSIBLE ITEMS USED INCLUDE THE: LUXTEC (B) (4) HEAD LIGHT CABLE (THIS IS NOT AN INSTRUMENT CABLE) IS USED WITH THE SNOWDEN PENCER RETRACTOR. SNOWDEN PENCER FIBER OPTIC CABLE (PART# UNK). SNOWDEN PENCER RETRACTOR PART #88-1087. PILLING-XENALIGHT-300 (LIGHT SOURCE-PART# UNK). SNOWDEN PENCER CONNECTORS (PART# UNK). ON (B) (6) 2010, CONVERSATION WITH RISK MGR - SHE STATES, THEY THINK, THE BURN WAS CAUSED BY THE SNOWDEN PENCER CABLE, NOT THE LUXTEC CABLE. DEGREE OF INJURY WAS ALSO REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE HEADLIGHT STANDARD 7.5FT NA EQH INTEGRA LUXTEC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1