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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC RANGER GVL 4; VIDEO LARYNGOSCOPE
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VERATHON MEDICAL ULC RANGER GVL 4; VIDEO LARYNGOSCOPE Back to Search Results
Model Number RANGER GVL 4
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 05/10/2015
Event Type  malfunction  
Event Description
While completing incoming inspection, the end user discovered that the end of the blade is slightly split and sharp to the touch.There was no effect on patient safety.
 
Manufacturer Narrative
Device eval summary: visually inspected blade and could not reproduce she issue of blade splitting and having a sharp edge.On (b)(6) 2013 safety alert notice c/r 3022472-5-07-2013-0001-c was issued to all customers to provide additional safety information to remind users to carefully examine blades before and after each use, and promptly replace any that show signs of wear or damage.
 
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Brand Name
RANGER GVL 4
Type of Device
VIDEO LARYNGOSCOPE
Manufacturer (Section D)
VERATHON MEDICAL ULC
burnaby, bc
CA 
Manufacturer Contact
brian anderson
2001 north creek pkwy
bothell, WA 98011
8003312313
MDR Report Key4898327
MDR Text Key6538466
Report Number9615393-2015-00056
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRANGER GVL 4
Device Catalogue Number0574-0018
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/29/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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