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

Model Number 0570-0382

Device Problems No Display/Image (1183); Poor Quality Image (1408)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated; however, at the time of the report the device has 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 cut out.The customer's biomed narrowed the issue to the baton.A delay in the procedure of two (2) minutes occurred as a backup glidescope video baton 2.0 large was obtained.No harm to the patient or user was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10 a replacement glidescope video baton 2.0 large was provided to the customer and the video baton 2.0 large used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton 2.0 and confirmed that when the baton was manipulated the image intermittently cut out.The intermittent image issue was isolated to baton failure.Since the customer had already received a replacement video baton 2.0, the returned glidescope video baton 2.0 large was scrapped.No corrective action is required at this time.Verathon will continue to monitor for trends.

• 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: 10505342
• MDR Text Key: 207757590
• Report Number: 9615393-2020-00161
• 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: 06/30/2020

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: 10/01/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1