MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA BRONCHOFIBERVIDEOSCOPE; BRONCHOVIDEOSCOPE

Model Number	BF-XP160F
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that error codes indicating a scope communication error were detected during a flexible bronchoscopy with bronchoalveolar lavage while using an evis exera iii xenon light source.An evis exera iii video system center and an evis exera bronchofibervideoscope were also used at that time.The procedure was delayed for 45 minutes with the patient under sedation, prolonging testing and delaying care of a critically ill patient.The procedure was completed with a different scope and another travel cart was made available in case the event occurred again.There was no further harm reported.The customer confirmed that the scope and video processor were used again in another procedure with no issues noted.Only the light source was returned to olympus.Since the root cause of the reported malfunction that caused the delay was not known, all three devices used in the procedure are being reported.This event is reported under the following related patient identifiers: (b)(6) - light source.(b)(6) - video processor.(b)(6) - bronchoscope.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 16915259
• Report Number: 2429304-2023-00095
• Device Sequence Number: 6423367
• Product Code: EOQ
• UDI-Device Identifier: 04953170340116
• UDI-Public: 04953170340116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2023
• Report Date (Section F): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BF-XP160F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLV-190/7775326; CV-190/7748747
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown