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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON INC. GVL 4 STAT GLIDESCOPE COVER; LARYNGOSCOPE, RIGID
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VERATHON INC. GVL 4 STAT GLIDESCOPE COVER; LARYNGOSCOPE, RIGID Back to Search Results
Lot Number GF49538
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/21/2019
Event Type  Injury  
Event Description
During a difficult intubation in the emergency department on this elderly gentleman, the ed physician was using a glidescope with a disposable plastic cover that broke during use.Visualization was not adequate, so the physician retracted the glidescope to find that the tip of the disposable plastic cover, approximately 2 inches in length, had broken off in the patient¿s throat and had become lodged.Upon opening a second glidescope cover the tip was found to be nearly severed in the package.The patient was successfully intubated with the plastic tip remaining in the patient¿s throat for less than 30 minutes when a crna was notified and was able to remove the retained plastic cover tip using a glidescope and special tool without harm.
 
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Brand Name
GVL 4 STAT GLIDESCOPE COVER
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
VERATHON INC.
MDR Report Key8394166
MDR Text Key137995804
Report NumberMW5084670
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2021
Device Lot NumberGF49538
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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