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 Orientation Incorrect (1305)

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

Event Date 03/10/2021

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 would flicker.The customer narrowed the image flickering to a failed connection between the glidescope video baton 2.0 and the core smart cable.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.The video baton 2.0 used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope video baton 2.0 large but was unable to confirm the reported "intermittent image" issue.When the video baton was connected to known, good, test equipment, the image was normal.The camera image quality test was performed and passed.The technical service representative observed that the video baton's lens cover had plastic missing.Since the glidescope video baton 2.0 large is not repairable and a replacement was already provided to the customer, the glidescope video baton 2.0 large used in the procedure was scrapped.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.".

• 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: 11624234
• MDR Text Key: 249331432
• Report Number: 9615393-2021-00083
• 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: 03/10/2021

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: 05/26/2021
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1