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); Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371)

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

Event Date 04/12/2022

Event Type  malfunction  

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 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.

Manufacturer Narrative

A replacement glidescope video baton 2.0 large and glidescope core smart cable were provided to the customer and the reported video baton was returned to verathon along with the smart cable used in the procedure.A verathon technical service representative evaluated the returned glidescope video baton 2.0 large 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.The verathon technical service representative next evaluated the returned glidescope core smart cable.When connecting the returned smart cable to known, good, test verathon equipment, the video image was normal.The camera image quality test was performed for the smart cable and passed.Upon completion of the evaluation the glidescope video baton 2.0 large and glidescope core smart cable were both scrapped as they had already 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: 14346713
• MDR Text Key: 299895050
• Report Number: 9615393-2022-00088
• 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
• Date Device Manufactured: 11/25/2021
• 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