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); Display or Visual Feedback Problem (1184)

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

Event Date 09/18/2023

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

A customer reported that during a patient procedure, using a glidescope titanium lopro t3 reusable video laryngoscope, the blade lost video connection.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The reported glidescope titanium lopro t3 reusable laryngoscope used during the procedure was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned device but was unable to confirm the reported loss of image.When connected to known, good, test verathon equipment, it produced a normal image.Stress testing the laryngoscope did not produce any image issues or loss of image.The connection between the laryngoscope and test cables was confirmed to be fully seated and locked with the laryngoscope.The tsr was unable to induce a connection failure.The glidescope titanium lopro t3 reusable laryngoscope passed verathon's functionality testing.Neither the cable nor the monitor used with the glidescope titanium lopro t3 reusable laryngoscope were made available to verathon for evaluation.Upon completion of the evaluation, the glidescope titanium lopro t3 reusable laryngoscope was returned to the customer.No further investigation is required at this time.Corrective action is not 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; verathon medical ulc; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 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: 17949616
• MDR Text Key: 325920449
• Report Number: 9615393-2023-00189
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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