BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESCOPE GVL 5

    MDR report key: 3049553 · Received April 5, 2013

    Report

    Report Number
    9615393-2013-00104
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL HAS INFORMED VERATHON INC THAT THEY WILL RETAIN THE DEVICE FOR 2 YEARS. VERATHON INC HAS AN ONGOING INVESTIGATION REGARDING THIS FAILURE MODE. THIS COMPLAINT WILL BE INCLUDED IN THAT INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A GLIDESCOPE GVL 5 BLADE THAT CRACKED DURING INTUBATION OF A PT. FRAGMENTS OF THE BLADE WEE LODGED IN THE PT'S THROAT. THE HOSPITAL USED ANOTHER SCOPE TO REMOVE THE FRAGMENTS FROM THE PT'S LARYNX. THERE WAS SELLING/CUTS AND BRUISING OF PT LARYNX AFTER BLADE CRACKED DURING INTUBATION. DUE TO THE INCIDENT THE HOSPITALIZATION WAS PROLONGED FOR THE PT. THE ESOPHAGOSCOPY PROCEDURE WAS CANCELLED AND THE PT WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140104 GLIDESCOPE GVL 5 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0574-0030

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention