MAUDE Adverse Event Report: GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	0570-0374
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope bflex 5.0 bronchoscope was forwarded to verathon (b)(4) for further investigation.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 or Problem Description
The customer reported that during a patient procedure, using a glidescope bflex 5.0 bronchoscope, the image would go dark.A delay in the procedure of an unknown duration occurred as an undisclosed device was obtained.No harm to the patient or user was reported.
Additional Manufacturer Narrative
The glidescope core 15-inch monitor used in the procedure was returned to verathon for evaluation.The core 15-inch monitor was forwarded to the sustaining engineering team in burnaby, canada for in-depth analysis.Due to the extensive testing performed by the sustaining engineering team, it was thought that the device might have incurred damage, so verathon, as a precaution, took the initiative to replace the core monitor.The sustaining engineer was unable to confirm the dark image issue.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 BFLEX 5.0 BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• MDR Report Key: 11624254
• Report Number: 9615393-2021-00095
• Device Sequence Number: 3157314
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS210500(17)220129
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183256
• 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 faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS210500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 10/17/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1