MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GVL 3; LARYNGOSCOPE, RIGID

Model Number GLIDESCOPE GVL 3

Device Problem Material Frayed (1262)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Technical services evaluated the returned product and confirmed the sharp edge.The tether was partially detached from the blade and the remains of the damaged tether on the side of the blade was sharp.They also discovered large cracks on the serial number side of the blade.There are no repairs available for the cracked housing.A replacement blade is required.This blade was staged for scrap.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 cleaning of a glidescope gvl 3, the end cap fell out leading to exposed wires on the side of the blade.The user reported that she received a small cut from the exposed wires.

• Brand Name: GLIDESCOPE GVL 3
• 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 Key: 5499295
• MDR Text Key: 40299188
• Report Number: 9615393-2016-00304
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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 Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLIDESCOPE GVL 3
• Device Catalogue Number: 0574-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention