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); Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core smart cable, the image flickered, froze, or disconnected.The customer stated there was a loose cable connection which caused video interruptions when in use.The customer had to unplug/replug the hdmi connection between the video baton and smart cable to restore video, and then brace the video baton and smart cable hdmi connection together to ensure the continuity of video.No use of a backup device or 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

The customer's glidescope core smart cable and glidescope video baton 2.0 large were replaced, and the reported cable and video baton were returned to verathon for evaluation.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue but only with the glidescope video baton 2.0 large.The glidescope core smart cable passed visual inspection and produced a normal image when connected to verathon test equipment with no issues found during evaluation testing.The camera image quality test was performed for the glidescope core smart cable and passed.During visual inspection of the glidescope video baton 2.0 large, it was noted that the connector pins were corroded.The video baton produced an intermittent image when connected to verathon test equipment.Manipulating the connection to the video baton caused the image to flicker with horizontal green lines and then the test monitor ceased to recognize the video baton.The camera image quality test was performed for the glidescope video baton 2.0 large and failed.Upon completion of the evaluation, both the glidescope core smart cable and video baton 2.0 were scrapped due to the customer already being provided replacement devices.The glidescope products reprocessing manual states: "use hospital-grade clean air to blow remaining moisture out of the connectors, and then dry the component using hospital-grade clean air." it is likely that not blowing out the connector with hospital-grade air caused or contributed to the corrosion in the hdmi connector.Verathon followed up with the customer and restated the importance of blowing out the connectors following the reprocessing of the video baton.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: 14142432
• MDR Text Key: 298935563
• Report Number: 9615393-2022-00072
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• 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