MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0404

Device Problems Display Difficult to Read (1181); No Display/Image (1183); Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2021

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

The customer reported that during a patient procedure, using a glidescope core 15-inch monitor, the image would cut in and out and a red color distortion occurred.The customer disconnected the bflex bronchoscope and reconnected it several times, and even tried another bronchoscope, but the issue persisted.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

The glidescope core 15-inch monitor was returned to verathon for evaluation along with the customer's glidescope core smart cable and glidescope quickconnect cable.A verathon technical service representative evaluated the returned devices but was unable to reproduce neither the image cutting in-and-out or a red color distortion issue.The camera image quality test was performed and passed.Upon completion of the evaluation the glidescope core 15-inch monitor and new glidescope quickconnect cable were returned to the customer, and the glidescope core smart cable was scrapped due to it already having being replaced.Verathon has completed its investigation of the reported dark image issue for the combination of the glidescope 15-inch monitor in conjunction with a glidescope bflex single-use bronchoscope in capa-2021-0003.Measurements of the analog video signal were taken when a dark image was displayed.The analog video clock signal timing was observed to be delayed, resulting in the transmission of the dark image.A design review was conducted, the delay was determined to be result of two resistor sets in the bflex receptacle.Improving one or both resistor sets was shown to reduce or eliminate the instances of dark image.Verification samples were produced with the component improvements made on the bflex receptacle, design verification was completed, and an engineering change order (eco) was released to implement the changes.As part of the investigation a post launch risk assessment (plra) was performed.The plra determined that the observed severity and probability of occurrence for this failure mode were in alignment with the predicted severity and probability of occurrence.During the plra, complaint data was reviewed.In all instances the user completed an unplug/plug sequence to restore functionality or switched to a backup device to complete the procedure.No adverse events were reported.Based on this review of the system risk assessment and the complaint data no additional action is required, verathon will continue to monitor for trends.All forward production incorporates this change.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• 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: 11881980
• MDR Text Key: 255671538
• Report Number: 9615393-2021-00148
• 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: 04/29/2021

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: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• 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