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

Model Number 0570-0382

Device Problems Display or Visual Feedback Problem (1184); Protective Measures Problem (3015); Intermittent Loss of Power (4016)

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

Event Date 05/03/2021

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 device would intermittently disconnect, and an error message would appear on the monitor screen.The customer did not report a delay in the procedure, use of a backup device, or harm to the patient or user.

Manufacturer Narrative

A replacement glidescope video baton 2.0 large and a glidescope core smart cable were 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 video baton 2.0 and confirmed, the reported intermittent disconnect issue.When connected to known, good, test equipment, the video baton 2.0 produced a split screen image.And then, intermittently, ceased to be recognized by the test monitor.The camera image quality test was performed and failed.The technical service representative attributed the poor image quality to baton failure.The glidescope core smart cable was connected to known, good, test equipment and produced a normal image.The camera image quality test was performed and passed.Since the glidescope video baton 2.0 large is not repairable, and replacements were already provided to the customer, the video baton 2.0 and core smart cable, used in the procedure were scrapped.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
• MDR Report Key: 11881891
• MDR Text Key: 255671918
• Report Number: 9615393-2021-00147
• 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: 05/03/2021

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: 06/28/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1