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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE® GVL® 4; LARYNGOSCOPE, RIGID
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VERATHON MEDICAL ULC GLIDESCOPE® GVL® 4; LARYNGOSCOPE, RIGID Back to Search Results
Model Number GLIDESCOPE® GVL® 4
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2016
Event Type  malfunction  
Manufacturer Narrative
Technical services evaluated the returned product and confirmed the dents and splintering of the blade.Customer caused issue by mishandling of the device.The product was evaluated for the reported malfunction and the malfunction will be tracked and trended to determine any additional actions.
 
Event Description
The customer reported that during an unknown time of discovery, a glidescope® gvl® 4 was found to have dents and the blade was splintering.It was unknown if a back-up device was reportedly used.No delay in the procedure was noted.No harm to patient or user was reported.
 
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Brand Name
GLIDESCOPE® GVL® 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
VERATHON MEDICAL ULC
2227 douglas road
burnaby, bc V5C 5 A9
CA  V5C 5A9
Manufacturer Contact
brian anderson
20001 north creek parkway
bothell, WA 98011-8218
4256295674
MDR Report Key5499292
MDR Text Key40303097
Report Number9615393-2016-00296
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGLIDESCOPE® GVL® 4
Device Catalogue Number0574-0001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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