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

Model Number	TJF-Q190V
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported on behalf of a user facility to olympus that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) with an evis exera iii duodenovideoscope the single use distal cover fell off inside the patient's larynx.The doctor was able to get the single-use distal cover into the stomach of the patient where the distal cover was safely retrieved and removed.There was no surgical delay, and no other devices were involved in the event.The intended procedure was completed; however, the same device was not used to complete the procedure.There were no irregularities with the unused single-use distal cover before or after attaching the cover onto the duodenoscope.No anti-fog agent was applied to the scope lens.The tip cover was attached to the scope and then pulled or twisted to make sure the cover did not come off prior to use.The single-use distal cover was disposed of after it was retrieved.No patient harm reported.This is related to patient identifier number (b)(6) which was reported under mfr.Report number 8010047-2021-09917.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3500 corporate parkway; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 16300905
• Report Number: 2429304-2023-00015
• Device Sequence Number: 6783462
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2023
• Report Date (Section F): 07/15/2021

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: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2023
• 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: MAJ-2315: LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown