BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE GVL 5

    MDR report key: 3810888 · Received March 19, 2014

    Report

    Report Number
    9615393-2014-00012
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    VERATHON MEDICAL ULC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-1558-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: AN INSPECTION SHOWED THE BLADE TIP WAS BROKEN OFF AT THE CAMERA. THERE WAS ALSO TIP SEPARATION, DELAMINATION, AND A CRACKED LENS COVER. THE DEVICE HAD BEEN IN USE FOR APPROX 1.5 YRS. THIS DEVICE WAS PART OF A GLIDESCOPE PRODUCT RECALL (Z-1558-2013), AND THE CUSTOMER RETURNED A CONFIRMATION FORM TO VERATHON ON (B)(4) 2013 STATING THAT USERS THROUGHOUT THEIR FACILITY WERE NOTIFIED OF THE RECALL. ON THE FORM, THE CUSTOMER WAS ASKED TO PROVIDE A LIST OF AFFECTED DEVICES IN THEIR POSSESSION, BUT THEY DID NOT LIST ANY DEVICES, AND INDICATED THAT THEY DID NOT HAVE ANY GLIDESCOPES WHICH FELL UNDER THE RECALL. IN ADDITION, A SAFETY ALERT NOTICE C/R 3022472-5-07-2013-0001-C WAS ISSUED TO ALL CUSTOMERS ON (B)(4) 2013 TO PROVIDE ADD'L SAFETY INFO TO REMIND USERS TO CAREFULLY EXAMINE BLADES BEFORE AND AFTER EACH USE, AND PROMPTLY REPLACE ANY THAT SHOW SIGNS OF WEAR OR DAMAGE. THE CUSTOMER WAS SENT A REPLACEMENT GLIDESCOPE AFTER THE COMPLAINT WAS REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT AFTER REMOVING THE GLIDESCOPE VIDEO LARYNGOSCOPE FROM A PT, HE NOTICED A CRACK ON THE BLADE. THE CRACK WENT FROM THE TOP TO BOTTOM SEAM NEXT TO THE CAMERA. THERE WAS NO HARM TO THE PT. ON RETURN TO VERATHON, THE GLIDESCOPE TIP WAS FOUND TO BE BROKEN OFF AT THE CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163320 GLIDESCOPE GVL 5 VIDEO LARYNGOSCOPE CCW VERATHON MEDICAL ULC. 0574-0030

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR