BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 1500X RF GENERATOR

    MDR report key: 2960926 · Received February 11, 2013

    Report

    Report Number
    1056436-2013-00007
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K992693
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS HAS REQUESTED THE RETURN OF THE DISPOSABLE DEVICE, DISPERSIVE ELECTRODES AND 150X GENERATOR FOR EVALUATION. PATIENT INFORMATION WAS REQUESTED AND IS AS FOLLOWS: THE PATIENT IS A FEMALE PATIENT AND THE PATIENT AGE IS UNKNOWN AT THIS TIME. THE PATIENT HAD NO HISTORY OF PERIPHERAL VASCULAR DISEASE. THE DISPERSIVE ELECTRODES WERE PLACED AS PER THE IFU AND THE DEGREES OF BURNS WERE NOT SPECIFIED BY THE USER FACILITY. THE PATIENT'S BURNS WERE BEING TREATED EVERY TWO (2) DAYS BUT THE TYPE OF MEDICATION BEING USED WAS NOT SPECIFIED BY THE USER FACILITY. THE CURRENT STATUS OF THE PATIENT AFTER THE BURN HAS BEEN REQUESTED BY ANGIODYNAMICS BUT AT THIS TIME IS UNKNOWN. THE USER MANUAL, WHICH IS SUPPLIED TO THE USER WITH THIS RFA GENERATOR, CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: "THE USE AND PROPER PLACEMENT OF A DISPERSIVE ELECTRODE IS A KEY ELEMENT IN THE SAFE AND EFFECTIVE USE OF MONOPOLAR ELECTROSURGERY, PARTICULARLY IN THE PREVENTION OF BURNS. FOLLOW DIRECTIONS AND RECOMMENDED PRACTICES FOR THE PREPARATION, PLACEMENT, SURVEILLANCE, REMOVAL AND USE OF ANY DISPERSIVE ELECTRODE USED WITH THIS RF GENERATOR IN ACCORDANCE WITH YOUR FACILITY'S STANDARD OPERATING PROCEDURE, THE DISPERSIVE ELECTRODE'S INSTRUCTION FOR USE, AND AAMI STANDARDS." AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. ADDITIONAL BRAND NAMES: STARBURST XL, 9 ARRAY, 3-5CM, 15CM, COMMON DEVICE NAME: RFA PROBE; CATALOG#: 700-101320, LOT#: 571163, EXPIRATION DATE: 04/30/2015; BRAND NAME: DISPERSIVE ELECTRODE (TIN/KATECHO), COMMON DEVICE NAME: RFA ELECTRODE, CATALOG#: 700-102623, LOT#: Y030S12-17-2015/04.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013 BY THE USER IN (B)(6), ON (B)(6) 2012, AN ELDERLY FEMALE PATIENT PRESENTED FOR A RADIO FREQUENCY ABLATION OF A KIDNEY TUMOR (CANCER). A CT SCAN WAS PERFORMED AND THE PATIENT WAS PLACED UNDER ANESTHESIA. DISPERSIVE ELECTRODE GROUNDING PADS WERE PLACED ON BOTH OF THE PATIENT'S LEGS. THE SINGLE USE RF PROBE WAS INSERTED TO THE TARGET AREA AND THE RFA GENERATOR WAS ACTIVATED. IT WAS REPORTED THAT THE LENGTH OF THE ABLATION WAS APPROXIMATELY 20 MINUTES. DURING THE COURSE OF THE PROCEDURE, THE PATIENT COMPLAINED OF PAIN WITHOUT MENTIONING THE PRECISE LOCATION. AFTER THE PROCEDURE WAS COMPLETED, SKIN BURNS WERE NOTED ON THE PATIENT'S RIGHT LEG AT THE SITE OF THE DISPERSIVE ELECTRODE GROUNDING PADS. THE PATIENT IS CURRENTLY IN GERIATRIC DEPARTMENT OF HOSPITAL RECEIVING TREATMENT EVERY TWO DAYS FOR THE BURNS. NO OTHER HARM OR INJURY WERE REPORTED DUE TO THIS PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59813 MODEL 1500X RF GENERATOR RFA GENERATOR GEI ANGIODYNAMICS A021386

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R