MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM LOPRO S3; LARYNGOSCOPE, RIGID

Model Number 0574-0221

Device Problems Defective Device (2588); Optical Problem (3001)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The glidescope spectrum lopro s3 was received by our technical service department but has not been analyzed yet.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 spectrum lopro s3, there was no light at the blade after connecting to the monitor.A delay in the procedure of an unreported duration occurred as a backup spectrum lopro s3 was obtained.No harm to the patient or user was reported.

Manufacturer Narrative

A replacement glidescope spectrum lopro s3 was provided to the customer.The spectrum lopro s3 used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned spectrum lopro s3 and confirmed the led failure; the blade's led failed to illuminate when connected to known, good, test equipment.The camera image quality test was performed and passed.The technical service representative attributed the led failure to an led issue.Since the glidescope spectrum lopro s3 is not repairable and a replacement was already provided to the customer, the spectrum lopro s3 used in the procedure was scrapped.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM LOPRO S3
• 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: 12269109
• MDR Text Key: 266847444
• Report Number: 9615393-2021-00233
• 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: 07/07/2021

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: 0574-0221
• Device Catalogue Number: 0270-1078
• Device Lot Number: UT77293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1