BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESCOPE GVL

    MDR report key: 2597437 · Received May 29, 2012

    Report

    Report Number
    MW5025601
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    May 18, 2012
    Report Date
    May 29, 2012
    Manufacturer
    VERATHON MEDICAL , INC
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT A TOTAL THYROIDECTOMY AND WAS NOTED TO HAVE SYMPTOMS OF AN AIRWAY PROBLEM IN THE IMMEDIATE POSTOPERATIVE PERIOD. THE PT WAS IMMEDIATELY RETURNED TO SURGERY AND A PIECE OF HARD BLUE PLASTIC MEASURING 3/4 INCH X 1/2 INCH WAS RETRIEVED FROM THE PT'S THROAT. THE ITEM WAS FOUND TO BE A PART OF THE GLIDESCOPE DVL BLADE WHICH COVERS THE TOP OF THE CAMERA LENS. THE PART DID NOT APPEAR TO BE BROKEN, BUT SEEMS TO HAVE POPPED OFF. THE GLIDESCOPE IS AN INSTRUMENT USED TO FACILITATE INTUBATION IN PTS WHO ARE OTHERWISE DIFFICULT TO INTUBATE. THIS PARTICULAR GLIDESCOPE IS ONE OF THREE USED BY THE HOSP ON AVERAGE ONCE PER DAY. THERE WERE NO PREVIOUSLY REPORTED PROBLEMS WITH THE PRODUCT. THIS PARTICULAR GLIDESCOPE WAS PURCHASED APPROX FIVE YEARS AGO AND IS THE FIRST OF THREE PURCHASED FOR USE IN THIS FACILITY. THE PRODUCT HAS BEEN CARED FOR ACCORDING TO THE MFR'S SPECS USING HIGH LEVEL DISINFECTION. AGAIN, WE NOTE THAT THE PIECE THAT DISLODGED WAS PART OF THE PRODUCT DESIGN. IT CAN BE SNAPPED BACK INTO THE SPACE WHERE IT USED TO BE, BUT HAS NEVER BEEN INTENTIONALLY REMOVED PRIOR TO THIS INCIDENT. THE OTHER TWO BLADES (SAME MFR) USED IN THIS FACILITY ARE NOT DESIGNED IN THIS MANNER. THE DESIGN HAS EVIDENTLY BEEN CHANGED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDESCOPE GVL GLIDESCOPE (BLADE) CCW VERATHON MEDICAL , INC GVL 4

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R