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

Model Number 0574-0126

Device Problem Poor Quality Image (1408)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

A replacement glidescope titanium lopro t3 reusable laryngoscope was provided to the customer and the subject glidescope titanium lopro t3 reusable laryngoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned laryngoscope and was able to confirm the reported image issue.When connected to known, good, test verathon equipment, the laryngoscope produces a poor quality image.Visual inspection determined the issue to be isolated to a scratched lens.The device failed verathon's functionality testing.The glidescope video laryngoscopes operations and maintenance manual (omm) notes, "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." additionally, the glidescope video laryngoscopes omm states, "when cleaning video laryngoscopes, do not use metal brushes, abrasive brushes, scrub pads, or rigid tools.They will scratch the surface of the unit or the window protecting the camera and light, which may permanently damage the device." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure and following the required reprocessing methods.Upon completion of verathon's device evaluation, the device was scrapped due to the customer already being provided a replacement and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during a patient procedure, using a glidescope titanium lopro t3 reusable laryngoscope, the laryngoscope was no longer capable of use due to blurriness.It was reported that there were no cracks, scratches or moisture inside the laryngoscope's lens.The procedure was completed using a backup device which was made available in an unspecified amount of time.No delay in the procedure or harm to the patient was reported.

• Brand Name: GLIDESCOPE TITANIUM LOPRO T3 REUSABLE 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: 18789620
• MDR Text Key: 337205786
• Report Number: 9615393-2024-00041
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

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: 0574-0126
• Device Catalogue Number: 0574-0147
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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