MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM LOPRO S4; LARYNGOSCOPE, RIGID

Model Number 0574-0195

Device Problems Electrical /Electronic Property Problem (1198); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

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.

Event Description

The customer reported that during a patient procedure, using a glidescope spectrum lopro s4, the blade's light went out.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10.A replacement glidescope spectrum lopro s4 was provided to the customer.The spectrum lopro s4 used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the customer's returned spectrum lopro s4 and confirmed the reported led issue.The technical service representative reported that the spectrum lopro s4 failed to illuminate the leds.The technical service representative attributed the illumination problem to an led issue.The camera image quality test was performed and passed.Since no repair is available for the glidescope spectrum lopro s4 and the customer was already provided a replacement, the returned spectrum lopro s4 was scrapped.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM LOPRO S4
• 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: 11915660
• MDR Text Key: 256710614
• Report Number: 9615393-2021-00119
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: GU68542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1