MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE AVL VIDEO BATON 3-4; LARYGNOSCOPE, RIGID

Model Number 0570-0313

Device Problems Erratic or Intermittent Display (1182); Intermittent Loss of Power (4016)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2020

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.Upon review of the device history for serial number (b)(4), it was determined that the device was manufactured on (b)(6) 2016 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).

Event Description

The customer reported that during a patient procedure, using a glidescope avl video baton 3-4, the picture cut in and out.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D10, g4, g7, h2, h3, h6, h10.The glidescope avl video baton 3-4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope avl video baton 3-4 and could not reproduce the reported fault; the unit functioned as intended.The technician did note physical damage to the camera housing and returned the baton to the customer "as-is".Upon review of the device history for serial number (b)(6), it was determined that the device was manufactured on 27 dec 2015 and is past the two (2) year expected product life as outlined in the glidescope operations and maintenance manual (omm).Due to the age of the device and the fact that there are no repairs available for the video baton the customer was advised to replace their glidescope avl video baton 3-4.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." at this time, the cause of the reported camera housing damage could not be determined; however, it is likely that the age of the device, 4.3 years, caused or contributed to the event.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE AVL VIDEO BATON 3-4
• Type of Device: LARYGNOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 10070767
• MDR Text Key: 191810452
• Report Number: 9615393-2020-00105
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0313
• Device Catalogue Number: 0570-0313
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1