BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE INSUL. COATED BLADE

    MDR report key: 4192375 · Received October 22, 2014

    Report

    Report Number
    1717344-2014-00922
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INCIDENT ELECTRODE FOUND THE BLUE INSULATION WAS TORN AND SCRATCHED ALONG THE ENTIRE LENGTH OF THE INSULATION. THE TORN AND DAMAGED BLUE INSULATION CAUSED THE CLEAR PTFE INSULATOR TO DISENGAGE. THE INSTRUCTIONS FOR USE STATE THAT CLEANING THE ELECTRODE WITH A SCRATCH PAD OR OTHER ABRASIVE OBJECTS, SCRAPING WITH A SHARP OBJECT OR BENDING BEYOND 90 DEGREES MAY DAMAGE THE ELECTRODE. IF THE ELECTRODE BECOMES DAMAGED, IT SHOULD BE DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PLASTIC PIECE FELL INTO THE OPEN INCISION DURING A LAMINECTOMY PROCEDURE. IT WAS RETRIEVED WITHOUT ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672310 EDGE INSUL. COATED BLADE ES ACCESSORY GEI COVIDIEN LP E1455 41960062X

    Patients

    Seq Age Sex Outcome Treatment
    1