MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID

Model Number 0570-0382

Device Problems Display or Visual Feedback Problem (1184); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Verathon's territory manager visited the customer and reviewed the device.He noted a pixilated image that was almost blurry but no frozen image nor loss of image.The device return is anticipated, however; at the time of the report the devices have not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the image was pixelated and would freeze intermittently.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10 the glidescope video baton 2.0 large was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton 2.0 large and confirmed the intermittent image freeze issue.The technical service representative noted obvious wear and tear to the hdmi connector which contributing to the failure.The cycle count was noted as 865.Glidescope video baton 2.0 large was scrapped and a replacement was sent to the customer.No corrective action is required at this time.Verathon will continue to monitor for trends.The glidescope operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged.".

• Brand Name: GLIDESCOPE VIDEO BATON 2.0 LARGE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 10707900
• MDR Text Key: 213700276
• Report Number: 9615393-2020-00218
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

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: 0570-0382
• Device Catalogue Number: 0570-0398
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1