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

Model Number	TJF-Q190V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a medwatch from the fda indicating during an endoscopic gastroduodenoscopy for diagnostic surveillance for duodenal tubulovillous adenomas, the single use distal cover fell of the duodenovideoscope while removing it and entered the patient's trachea, resulting in partial airway obstruction.It was later reported that the cover created an almost complete airway obstruction.Initially the patient was not under general anesthesia, but general anesthesia was initiated for an urgent flexible bronchoscopy by a pulmonologist to retrieve the cover.The patient was also scheduled for a colonoscopy that same day; therefore, resulting in a delay.After the bronchoscopy, the colonoscopy procedure was completed.The reporter also indicated the same type of flexible, disposable cap that was recently started at his institution, came off in another procedure and dropped into the hypopharynx of that patient.This complaint requires 4 reports.The related patient identifiers are as follows: two reports represent the initial reported event of the cap falling into the patients trachea (patient 1 of 2).(b)(6) represents evis exera iii duodenovideoscope.(b)(6) represents the single use distal cover.Two reports represent the reporters similar event of the cap falling into a patients hypopharynx (patient 2 of 2).(b)(6) represents evis exera iii duodenovideoscope.(b)(6) represents single use distal cover.This medwatch represents patient 1 of 2 for patient identifier (b)(6), evis exera iii duodenovideoscope.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 18287701
• Report Number: 2429304-2023-00389
• Device Sequence Number: 12138862
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2023
• Report Date (Section F): 11/09/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2023
• 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: SINGLE USE DISTAL COVER - LOT H2X20
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG