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

Model Number 0570-0382

Device Problem No Display/Image (1183)

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

Event Date 08/01/2022

Event Type  malfunction  

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.

Event Description

The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the image disappears upon placing the device into the patient's mouth.The customer reported the hdmi connection between the glidescope video baton 2.0 large and the smart cable has a "loose connection." no delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10.The reported glidescope video baton 2.0 large was returned to verathon along with the glidescope core smart cable used in the reported procedure.A verathon technical service representative evaluated the reported devices and was able to confirm several image issues found.When connecting the reported video baton to known, good, test verathon equipment, the image feed from the baton initially produced a flickering image with horizontal green lines.When manipulating the video baton's flex tube, the image would freeze and/or disappear entirely.The camera image quality test was performed and failed for the glidescope video baton 2.0 large.Next the verathon technical service representative evaluated the returned glidescope core smart cable and confirmed no issues were found.The reported image issues were determined to have been isolated to just the reported glidescope video baton 2.0 large.Upon completion of the evaluation the customer was notified of the reported image issues found to their glidescope video baton 2.0 large, with the recommendation to replace the video baton due to there being no repairs available for this device.Per request of the customer the glidescope video baton 2.0 large was scrapped, and the glidescope core smart cable was returned back to the customer.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: 15676770
• MDR Text Key: 302720766
• Report Number: 9615393-2022-00176
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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