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

Model Number 0570-0366

Device Problems No Display/Image (1183); Intermittent Loss of Power (4016)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The glidescope go monitor was returned to verathon for evaluation.A verathon technical service representative evaluated the returned go monitor and confirm the reported image issue.The camera image quality test was performed and failed.The verathon technical service representative noted a power management issue with the go monitor when evaluating the device.On visual inspection of the go monitor, the verathon technical service representative identified damage to the button and a crack to the housing where the monitor's hinge is located.The overlay and switch on the go monitor were reported as completely missing.Upon completion of the evaluation, the customer's glidescope go monitor was scrapped as being unrepairable, and the customer was sent a replacement glidescope go monitor.Corrective action is not required at this time.Verathon will continue to monitor for trends.The glidescope go 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.".

Event Description

The customer reported that during a patient procedure, using a glidescope go monitor, the device was "cutting off".The customer stated that the swivel where the go monitor's hdmi connector is located, was "too loose" causing the swivel to move while being used.No delay in the procedure, use of a backup device, or 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: 11844464
• MDR Text Key: 252245176
• Report Number: 9615393-2021-00134
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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