MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE TITANIUM LOPRO T3 REUSABLE VIDEO LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number 0574-0126

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Poor Quality Image (1408)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

A customer reported that during a patient procedure, using a glidescope titanium lopro t3 reusable video laryngoscope, the image was initially fine, but after a few minutes the image disappeared and then reappeared blurry.The procedure was completed using another blade which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient or user was reported.

Manufacturer Narrative

A loaner device was provided to the customer and the customer's glidescope titanium lopro t3 reusable video laryngoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device but was unable to confirm the reported image issue.The glidescope titanium lopro t3 reusable video laryngoscope passed both visual inspection and functional testing.No intermittent image failures were observed when manipulating the cable connector near the blade.As requested by the customer, a second evaluation was performed for their device by testing it with a known, good, test glidescope core monitor and glidescope core video cable but still no problems were identified.The camera image quality test was performed for the glidescope titanium lopro t3 reusable video laryngoscope and passed.At this time, the cause of the reported image issue could not be determined; however, the customer's video cable and monitor used with the reported video laryngoscope were not made available to verathon for evaluation.Upon completion of the evaluation, the glidescope titanium lopro t3 reusable video laryngoscope was returned to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE TITANIUM LOPRO T3 REUSABLE VIDEO LARYNGOSCOPE
• 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: 15625739
• MDR Text Key: 307037417
• Report Number: 9615393-2022-00175
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0126
• Device Catalogue Number: 0574-0147
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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