MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE AVL VIDEO BATON 3-4; LARYNGOSCOPE, RIGID

Model Number 0570-0307

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated, however; at the time of this report the device has not been received by verathon.Verathon will continue to investigate the reported event and a follow-up report will be submitted once additional information becomes available.

Event Description

A customer/distributor reported that during a patient procedure, using a glidescope video monitor (gvm) with a glidescope video baton 3-4, distortion/stripes appeared in the camera image.The customer reported a loose video baton connection.Follow-up information received from the distributor reported that during the initial incident on (b)(6) 2022, only stripes appeared in the display picture.Upon further evaluating the system on (b)(6) 2022, the distributor reported "the picture built up line-by-line from top to bottom.The process takes about 3 minutes until the image is completely built up." the distributor was unable to isolate the issue to the monitor or video baton.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D1, d4, d9, g3, g6, h2, h3, h4, h6, h10 the customer's glidescope avl video baton 3-4 was returned to verathon for evaluation along with their glidescope video monitor used during the reported event.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.The video baton passed visual inspection.When connecting the video baton to known, good, test verathon equipment, green stripes appeared on the screen followed by the "attach video cable" message/icon.The verathon technical service representative next evaluated the glidescope video monitor which passed both visual inspection and functional tests.The camera image quality test was performed for the monitor and passed.The reported image issue was isolated to just the glidescope avl video baton 3-4.Upon completion of the evaluation of the devices, the customer was notified of the evaluation findings and authorized the recommended repairs to replace the battery to their glidescope video monitor (gvm).The recommended repair to the glidescope video monitor was unrelated to the initial reported image issue, and was found by verathon technical service when evaluating the device.After completing all servicing activities, the glidescope avl video baton 3-4 was replaced and the serviced glidescope video monitor was returned to the customer along with a replacement video baton.Upon review of the device history for the glidescope avl video baton 3-4 serial number al173455, which the image issue was isolated to, it was determined that the glidescope avl video baton 3-4 was manufactured on november 30, 2017 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).It is likely that the age of the device, four (4) years and eight (8) months, may have caused or contributed to the reported event.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE AVL VIDEO BATON 3-4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 15075821
• MDR Text Key: 304001442
• Report Number: 9615393-2022-00123
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0307
• Device Catalogue Number: 0570-0313
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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