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

Model Number 0574-0116

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

This is an initial report and the product has not yet been received for evaluation.Should the device be returned, the device evaluation data will be included in a follow-up report.

Event Description

The customer reported that during a patient procedure, using a glidescope agvl 4, there was no image.No delay in the procedure or use of a back-up device was reported.No harm to patient or user was reported.

Manufacturer Narrative

This product was received and tested by technical services and the failure was (b)(6).The fault was determined to be an intermittent baton failure.There was an intermittent image with only stripes.The baton was also splitting and needed to be replaced.The protective cleaning cap and latch were missing.

• Brand Name: GLIDESCOPE AGVL 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: kent huthsing ; 20001 north creek pkwy; bothell, WA 98011-8218 ; 4258671348
• MDR Report Key: 5997082
• MDR Text Key: 56389176
• Report Number: 9615393-2016-00624
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0116
• Device Catalogue Number: 0574-0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2013
• 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