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); Loose or Intermittent Connection (1371); Poor Quality Image (1408)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

The customer was unable to confirm the exact serial number of the glidescope video baton 2.0 large used in the patient procedure event.Verathon is currently expecting to receive two of the customer's glidescope video baton 2.0 large to be returned for further investigation.However; at the time of this report the devices have not been returned to verathon.Verathon will continue to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 if additional information becomes available.

Event Description

The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the image goes "in-and-out" with black lines, when the connected glidescope core smart cable was manipulated.Due to the reported image going "in-and-out" with black lines the customer was unable to visualize properly on the connected glidescope core monitor.The customer reported that the hdmi connection between the video baton and smart cable was very "wiggly" and needed to be securely snapped into place.No harm to the patient or user was reported.

Manufacturer Narrative

The customer was unable to confirm the exact serial number of the glidescope video baton 2.0 large used during the reported patient procedure event.Verathon did however receive at a later date two (2) of the customer's glidescope video baton 2.0 large that may have been used in the reported patient procedure, along with two (2) of the customer's glidescope core smart cables.A verathon technical service representative began by evaluating one of the returned glidescope video baton 2.0 large (sn: (b)(6)) returned for evaluation and was able to confirm the reported issue.When connecting the customer's video baton to known, good, test verathon equipment, the video baton intermittently ceases to be recognized and produced a split-screen on the connected test monitor.The verathon technical service representative also reported seeing visible damage to the hdmi connector on the customer's video baton.The camera image quality test was performed and failed for the glidescope video baton 2.0 large (sn: (b)(6)).The verathon technical service representative next evaluated the other glidescope video baton 2.0 large (sn: (b)(6)) returned for evaluation.When visually inspecting the returned glidescope video baton 2.0 large, the verathon technical service representative reported seeing damage to the contacts on the video baton connector.The verathon technical service representative took the customer's video baton and smart cable that were returned, and connected them together to a known, good, test verathon monitor; the video image produced from the test monitor was normal.The verathon technical service representative began to manipulate both the video baton and smart cable while they were still connected to the test monitor, and the video image produced continued to remain normal.The video baton and smart cable were left connected to the test monitor for between three (3) to five (5) minutes with no reported issues observed.The camera image quality test was performed and passed for the glidescope video baton 2.0 large (sn: (b)(6)).Both returned glidescope core smart cables were confirmed to be working as intended with no issues found.The camera image quality test was performed for both glidescope core smart cables and passed.Upon completion of the evaluation the two (2) glidescope video baton 2.0 large and two (2) glidescope core smart cable were scrapped as they had all been replaced prior to their return for evaluation, and there being no repairs available for the devices.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: 14346711
• MDR Text Key: 299889429
• Report Number: 9615393-2022-00090
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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