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

Model Number	0600-0771
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core smart cable, the image was intermittent.No delay in the procedure, use of a backup device, or harm to the patient was reported.
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.
Additional Manufacturer Narrative
Upon receipt of the subject device from the customer, it was determined that the device information provided in verathon's initial mdr was incorrect.The correct device information has been provided in section d of this follow-up report.A replacement glidescope core video cable was provided to the customer and the reported glidescope core video cable used during the reported incident was returned to verathon.Due to initial miscommunication between the customer and verathon regarding the subject cable, the returned video cable was mistakenly disposed of and therefore no evaluation could be performed.The cause of the reported issue could not be determined.Review of complaint history for the reported glidescope core video cable lot number "16670-1-3" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope core video cable does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE VIDEO 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: 17435701
• Report Number: 9615393-2023-00142
• Device Sequence Number: 15697854
• Product Code: CCW
• UDI-Device Identifier: 00879123006547
• UDI-Public: (01)00879123006547(10)16670-1-3(11)221123
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: 16670-1-3
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown