MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO MONITOR (GVM); LARYNGOSCOPE, RIGID

Model Number 0570-0338

Device Problem No Display/Image (1183)

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

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

The glidescope video monitor (gvm) was returned to verathon for evaluation.A verathon technical service representative evaluated the returned monitor and confirmed the reported image issue.When the verathon technical service representative opened the monitor, the lcd wire harness was found partially disconnected from the main pcba and was not insulated with kapton tape.The verathon technical service representative reconnected the lcd wire harness and insulated it with kapton tape to resolve the issue.Upon completion of the evaluation, the glidescope video monitor (gvm) was returned to the customer.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glidescope video monitor (gvm), there was no image on the display.The customer was able to isolate the issue to the monitor by testing the device with several cables.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: GLIDESCOPE VIDEO MONITOR (GVM)
• 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: 11060974
• MDR Text Key: 224637963
• Report Number: 9615393-2020-00266
• 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: 11/25/2020

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: 0570-0338
• Device Catalogue Number: 0570-0338
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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