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

Model Number 0600-0783

Device Problems Display or Visual Feedback Problem (1184); Image Orientation Incorrect (1305); Poor Quality Image (1408)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's glidescope core smart cable was returned to verathon for evaluation along with their glidescope core 15-inch monitor and glidescope core quickconnect cable.A verathon technical service representative evaluated the returned devices but was unable to confirm the reported image issues.The monitor and both cables passed visual inspection.The technical service representative connected the customer's devices to known, good, test verathon equipment and they all passed functionality testing producing normal images.The camera image quality test was performed and passed.Upon completion of the evaluation, the customer's monitor and cables were sent to the verathon medical ulc office to be further evaluated by verathon's sustaining engineering department.A verathon sustaining engineer representative evaluated the customer's returned devices and was also unable to reproduce the failure in any of the devices.While the customer reported a glidescope spectrum single-use lopro s3 laryngoscope and a glidescope bflex single-use bronchoscope were connected to the monitor and cables during the reported event, both the single-use laryngoscope and single-use bronchoscope were disposed of and therefore could not be returned to verathon for evaluation.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during a patient intubation, using a glidescope core smart cable, the image on the connected glidescope core 15-inch monitor was flipped 180 degrees.It was reported that the provider and nursing staff tried to flip the screen back to normal but they were unable to correct it and performed a factory reset on the equipment.Additionally, it was reported that the light source for both the connected glidescope spectrum single-use lopro s3 laryngoscope and glidescope bflex single-use bronchoscope (exact model unknown) was extremely dark/dim.Due to being unable to visualize the patient's anatomy during the intubation, they reported having to use a backup glidescope video monitor (gvm) system to successfully intubate the patient.No delay in procedure or harm to the patient or user was reported.

• 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: 15233918
• MDR Text Key: 300243318
• Report Number: 9615393-2022-00130
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/21/2022

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: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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