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

Model Number 0600-0783

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 08/13/2023

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 spectrum single-use directview mac s3 laryngoscope, the screen on the connected glidescope core 10-inch monitor went blank.The monitor was previously evaluated by verathon and no issues were found.The customer also reported replacing the glidescope core smart cable but the issue was still not resolved.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The reported glidescope spectrum single-use directview mac s3 laryngoscope used during the procedure was not returned to verathon for evaluation.However, the customer returned a glidescope core 10-inch monitor and two glidescope core smart cables.A verathon technical service representative (tsr) evaluated the monitor but was found to be working as intended.Next, when connecting the customer's smart cables to known, good, test verathon equipment, a defect was found with one of the smart cables.The customer's smart cable failed verathon's device functionality testing.Upon completion of verathon's device evaluation, the customer was notified about verathon's findings and recommended the customer replace the faulty smart cable.The monitor and smart cable found to be functional were returned to the customer.Verathon also requested the customer return the subject glidescope spectrum single-use directview mac s3 laryngoscope to verathon for evaluation.To date, the device has not been received and the customer has not confirmed if it will be returned.Corrective action is not required at this time.Verathon will continue to monitor for trends.Please note that sections d and h of this final report were updated to reflect the glidescope core smart cable device information as the reported issue was determined to be isolated to this system component instead of the initially reported glidescope spectrum single-use directview mac s3 laryngoscope.

• Brand Name: GLIDESCOPE CORE SMART 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: 18311288
• MDR Text Key: 330287664
• Report Number: 9615393-2023-00227
• Device Sequence Number: 1
• Product Code: CCW
• 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
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1