MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE VIDEO CABLE; LARYNGOSCOPE, RIGID

Model Number 0600-0771

Device Problems Erratic or Intermittent Display (1182); No Visual Prompts/Feedback (4021)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope titanium lopro t3 reusable laryngoscope, the image intermittently freezes and disappears when manipulated.After the procedure, the customer's biomedical technician evaluated the device and reported the issue may be due to the glidescope titanium lopro t3 reusable laryngoscope and connected glidescope core video cable not fitting tightly at the connector, causing an interrupted connection.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the device has not been received by verathon.In follow-up communication with the customer, they provided verathon a photo of the reported glidescope titanium lopro t3 reusable laryngoscope used in the procedure.Based on the photo provided by the customer, there's evidence that may point to corrosion damage located in and around the connector of the reported video laryngoscope reusable blade as a possible contributing factor to the reported issue.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.

Manufacturer Narrative

The reported glidescope titanium lopro t3 reusable laryngoscope and glidescope core video cable used during the procedure were returned to verathon for evaluation.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.When connecting the customer's video cable to known, good, test verathon equipment, it showed intermittent loss of image.The customer's video cable failed verathon's device functionality testing.Next, when connecting the customer's lopro t3 reusable laryngoscope to known, good, test verathon equipment, it functioned as intended and passed verathon's device functionality testing.The issue was isolated to just the customer's glidescope core video cable.Upon completion of the device evaluation, a replacement video cable was provided to the customer as well as returning their lopro t3 reusable laryngoscope that was confirmed to be operating as intended.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE VIDEO CABLE
• 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: 16373037
• MDR Text Key: 309605911
• Report Number: 9615393-2023-00032
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006547
• UDI-Public: (01)00879123006547(10)15548-1-4(11)211129
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: 15548-1-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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