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

Model Number 0570-0313

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 06/30/2020

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.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.Upon review of the device history for serial number (b)(4), it was determined that the device was manufactured on 19 jun 2017 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 image was going in and out when the cable was moved.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

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 confirmed the poor image quality issue.The technical service representative attributed the image issue to cable failure.The glidescope avl video baton 3-4 was scrapped and a replacement was sent to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE AVL VIDEO BATON 3-4
• 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: 10350549
• MDR Text Key: 202533460
• Report Number: 9615393-2020-00163
• 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: 06/30/2020

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: 0570-0313
• Device Catalogue Number: 0570-0313
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1