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

Model Number 0570-0420

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

A replacement glidescope video baton quickconnect large was provided to the customer and the reported glidescope video baton quickconnect large used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and while they were unable to confirm the reported intermittent image, they did confirm the foggy/blurry image reported.When connecting the reported video baton to known, good, test verathon equipment, the image appeared "foggy." upon visual inspection of the reported video baton the verathon technical service representative identified cracks to the video baton's lens and damage to its housing cover.The glidescope video baton quickconnect large failed verathon's functionality testing.Upon completion of the evaluation the glidescope video baton quickconnect large was scrapped due to the customer already being provided a replacement and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.The glidescope video laryngoscopes operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.

Event Description

The customer reported that during a patient procedure, using a glidescope video baton quickconnect large, the image would intermittently disappear.When the image did reappear, the image appeared blurry.No delay in the procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE VIDEO BATON QUICKCONNECT 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: 16410237
• MDR Text Key: 309999953
• Report Number: 9615393-2023-00030
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0420
• Device Catalogue Number: 0270-1058
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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