MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GVL 4; LARYNGOSCOPE, RIGID

Model Number GLIDESCOPE GVL 4

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2013

Event Type  malfunction  

Manufacturer Narrative

This product has not been received back for evaluation at the time of this report.The problem cannot be confirmed.The customer is reminded to inspect the product for issues before use.The reported malfunction and the malfunction will be tracked and trended to determine any additional actions.

Event Description

Distributor reported the gvl 4 blade had a very sharp edge.There was no harm to any patient or any user associated with use of the blade.The blade was scrapped by the distributor.

• 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 ; 4256295674
• MDR Report Key: 5262934
• MDR Text Key: 32579485
• Report Number: 9615393-2015-00067
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/01/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLIDESCOPE GVL 4
• Device Catalogue Number: 0574-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1