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

Model Number	0600-0783
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
**udi related data quality updates only**.This is a supplemental report correcting the unique device identifier (udi) information in section d4.In the initial report submission, the udi information field was left blank due to the subject device (glidescope spectrum single-use directview mac s3 laryngoscope) lot number and manufacture date being unknown.Despite verathon being unable to obtain the lot information from the customer, this supplemental report provides the udi-di for the subject device model.Furthermore, the final report submission for this event contained the device information for the other device component (glidescope core smart cable) that the issue was determined to be isolated to, which included its serial number and manufacture date but no udi information was provided.As requested by the fda udi helpdesk team, this supplemental report also explains why the unique device identifier (udi) information in section d4 of verathon's final report submission was left blank.The subject device was manufactured and labelled prior to the udi compliance date for class i medical devices.Therefore, and as confirmed by the fda udi helpdesk team, the udi requirements for its associated mdr do not apply.

• Brand Name: GLIDESCOPE CORE SMART CABLE
• Common Device Name: 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
• Report Number: 9615393-2023-00227
• Device Sequence Number: 15022277
• Product Code: CCW
• UDI-Device Identifier: 00879123007803
• UDI-Public: (01)00879123007803
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/05/2024; Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/13/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown