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

Model Number 0600-0771

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem Hypoxia (1918)

Event Date 11/28/2022

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 an emergency care procedure, using a glidescope core video cable, the image on the connected glidescope core monitor became so pixelated that they aborted the video laryngoscopy attempt and placed the et tube with direct laryngoscopy instead due to the patient's oxygen saturations being in the 50s.The customer reported that the pixelated image issue was isolated to just the glidescope core video cable.No delay in the procedure or harm to the patient was reported.

Manufacturer Narrative

A replacement glidescope core video cable was provided to the customer and the glidescope core video cable used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned video cable and confirmed the reported image issue.When connecting the reported video cable to known, good, test verathon equipment, the image on the connected test monitor had green lines appear whenever the video cable's connector was manipulated.The glidescope core video cable failed verathon's functionality testing.Upon completion of the evaluation the glidescope core video cable was scrapped due to the customer already being provided a replacement and there being no repairs available for the cable.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: 16051963
• MDR Text Key: 308532574
• Report Number: 9615393-2022-00237
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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
• Device Operator: Health Professional
• Device Model Number: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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