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); Connection Problem (2900)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the devices have not been received by verathon.

Event Description

The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the connection between the baton and the smart cable was intermittently loose and causing the picture to go in and out.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

A replacement glidescope video baton 2.0 large was provided to the customer and the video baton 2.0 large used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video baton 2.0 and was unable to confirm the baton's loose connection to a known, good, test smart cable.Technical service representative connected the customer's video baton 2.0 into test equipment and no image issue was found.The camera image quality test was performed and passed.A visual inspection of the connector found the hdmi connector to be damaged.Since the customer had already received a replacement video baton 2.0, the returned glidescope video baton 2.0 large was scrapped.No further investigation is required at this time.Verathon will continue to monitor for trends.The glidescope 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.".

• 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
• MDR Report Key: 11446628
• MDR Text Key: 244599179
• Report Number: 9615393-2021-00055
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1