MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GO MONITOR KIT; LARYNGOSCOPE, RIGID

Model Number 0570-0366

Device Problem Intermittent Continuity (1121)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

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.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 go monitor, the picture was intermittent when the blade was connected.The customer reported that this occurred during two different patient procedures.(this report captures the first incident.The second incident is reported on 9615393-2021-00046.) a delay of an unknown duration occurred as an alternate glidescope unit was obtained.No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE GO MONITOR KIT
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 11399423
• MDR Text Key: 249330920
• Report Number: 9615393-2021-00040
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2021

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: 0570-0366
• Device Catalogue Number: 0570-0368
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1