BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINERGY COOLED RADIOFREQUENCY INTRODUCER

    MDR report key: 2853198 · Received November 30, 2012

    Report

    Report Number
    8030647-2012-00021
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. THE DEVICE HAS NOT YET BEEN RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ONCE SAMPLES ARE EVALUATED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(6), STATING, "THE INSULATION ON 2 OF 3 SI INTRODUCERS HAD PEELED BACK DURING THE PROCEDURE." NO PATIENT INJURY REPORTED.KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINERGY COOLED RADIOFREQUENCY INTRODUCER GXI KIMBERLY-CLARK HEALTH CARE M21-02-D201

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR