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

Model Number	0570-0404
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer declined to have their glidescope bflex 5.8 bronchoscope returned to verathon for evaluation.The complaint history record for the lot number ft210400 was reviewed with only one (1) additional complaint related to this lot number encountered.Should additional relevant information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
The customer reported that during an emergency care procedure, using a glidescope bflex 5.8 bronchoscope, the image on the screen blacked out.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.
Additional Manufacturer Narrative
The glidescope core 15-inch monitor was returned to verathon for evaluation.A verathon engineer evaluated the returned device and was able to reproduce the reported "dark image" issue.Due to the extensive testing done to this device to investigate the following issue, verathon has proactively decided to replace the customer's glidescope core 15-inch monitor with another.Upon completion of verathon's investigation a replacement glidescope core 15-inch monitor was sent to the customer.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.
Event or Problem Description
The customer reported that during an emergency care procedure, using a glidescope core 15-inch monitor with a glidescope bflex 5.8 bronchoscope, the image on the screen blacked out.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• 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: 12002853
• Report Number: 9615393-2021-00190
• Device Sequence Number: 17219820
• Product Code: CCW
• UDI-Device Identifier: 00879123006400
• UDI-Public: (01)00879123006400(10)FT210400(17)220122
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 01/22/2022
• 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: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• 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