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

Model Number	BF-3C160
Medical Device Problem Codes	Contamination (1120); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic bronchoscopy procedure (in a pediatric male patient) black particles/debris were noted in the airway at the beginning of the procedure that looked like a piece of black plastic.In an attempt to perform a foreign body procedure, the scope was removed from the airway, inspected for any defects and no obvious defects were noted on outside of the scope.Once the scope was reinserted the black material was no longer visible in the airway.The procedure was prolonged by hours along with anesthesia.No additional medical intervention was required and the procedure was completed but procedure extended for hours.The condition of the patient and the procedural outcome were not impacted by the issue.The scope was inspected prior to use and again after the black item was seen.There were no reports of patient harm.

• Brand Name: EVIS EXERA BRONCHOVIDEOSCOPE
• 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: 19643974
• Report Number: 2429304-2024-0000317
• Device Sequence Number: 12643916
• Product Code: EOQ
• UDI-Device Identifier: 04953170340031
• UDI-Public: 04953170340031
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2024
• Report Date (Section F): 06/17/2024

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-3C160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male