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

Model Number 0570-0382

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the image disappears on the connected glidescope go monitor's display.The customer reported that the video baton's connection to the glidescope go monitor was "loose." the procedure was completed using a backup glidescope system, which was made available in an unspecified amount of time.No harm to the patient was reported.

Manufacturer Narrative

The customer declined the option to have their glidescope video baton 2.0 large returned to verathon for evaluation.Due to the video baton not returning to verathon for evaluation, the cause of the reported issue could not be determined.Since the customer had identified the issue was isolated to just the glidescope video baton 2.0 large, the customer was advised to replace it.Upon review of the device history for the serial number "(b)(4)" it was determined that the device was manufactured on october 23, 2020 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 video baton 2.0 large.At this time, the cause of the reported issue could not be determined; however, it is likely that the age of the device, two (2) years and two (2) months, may have caused or contributed to the event.Review of complaint history for the reported video baton serial number "(b)(4)" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope video batons does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Corrective action is not 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
• 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: 16016322
• MDR Text Key: 308247006
• Report Number: 9615393-2022-00230
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/21/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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