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

Model Number 0570-0307

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been received by verathon, however; at the time of the report the device has not been evaluated.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

A customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the image on the connected glidescope video monitor (gvm) went blank while intubating the patient.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The customer's glidescope avl video baton 3-4 was returned to verathon for evaluation along with the glidescope video monitor used during the reported incident.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image failure.Visual inspection identified that the video baton's lens was scratched.When connected to known, good, test verathon equipment, the video baton produced a poor quality image and the image cut out entirely when manipulating its cable near the strain relief.The customer's glidescope avl video baton 3-4 failed verathon's device functionality testing.Next, the customer's glidescope video monitor was evaluated which passed both visual inspection and functionality testing.No failures were observed and the monitor functioned as intended.The issue was isolated to just the customer's glidescope avl video baton 3-4.Upon review of the device history for the glidescope avl video baton 3-4 serial number "(b)(6)" it was determined that the device was manufactured on june 12, 2012 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).Due to the age of the device and the fact that there are no repairs available for the video baton, the customer was advised to replace their glidescope avl video baton 3-4.It is likely that the age of the device, eleven (11) years and eight (8) months, may have caused or contributed to the event.The glidescope video laryngoscopes operations and maintenance manual (omm) notes, "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." additionally, the glidescope video laryngoscopes omm states, "when cleaning video laryngoscopes, do not use metal brushes, abrasive brushes, scrub pads, or rigid tools.They will scratch the surface of the unit or the window protecting the camera and light, which may permanently damage the device." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure and following the required reprocessing methods.Upon completion of verathon's evaluation, the video baton was scrapped due to there being no repairs available and the monitor was returned to the customer.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: 18789619
• MDR Text Key: 336347232
• Report Number: 9615393-2024-00030
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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 Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2012
• 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