BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9300XDP LIGHTSOURCE FAMILY TREE

    MDR report key: 2937267 · Received January 29, 2013

    Report

    Report Number
    1222895-2013-00001
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 2, 2010
    Report Date
    January 29, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER NOTED: 'ON (B)(6) 2012 THE PATIENT UNDERWENT A BILATERAL EXPLANTATION OF RUPTURED SILICONE IMPLANTS, A LEFT BREAST CAPSULOTOMY AND A RIGHT BREAST TOTAL CAPSULOTOMY. DURING THE PROCEDURE THE DOCTOR NOTED IN THE OPERATIVE REPORT AN INTEROPERATIVE COMPLICATION DID OCCUR. THERE WAS A SMALL BURN TO LEFT BREAST WITH THE CORD OF THE FIBER OPTIC RETRACTOR. THIS WAS DRESSED WITH SILVADENE'. THE PATIENT WAS ADVISED BY THE PHYSICIAN THAT "THE CORD MALFUNCTIONED WHILE I WAS CAUTERIZING. IT WA LYING ON YOUR CHEST". "AN INCORRECTLY SIZED CABLE CAUSED THE DEVICE TO BECOME EXTREMELY HOT WHICH RESULTED IN A SEVERE BURN AND SUBSEQUENT SCARRING TO THE PATIENT'S LEFT BREAST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39639 9300XDP LIGHTSOURCE FAMILY TREE LIGHTSOURCES KOG INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DYONICS LIGHT CORD 5 MM, REFERENCE NUMBER 2147| TEBBETTS FIBER OPTIC BREAST RETRACTOR| MANUFACTURER: SNOWDEN PENCER 88-1188