MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number	D-201-12704
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported; the hospital staff were asked to provide a distal cap for a diagnostic gastroscopy using a gastrointestinal videoscope.They did not have the appropriate size cap, and the doctor said to use the bigger disposable distal attachment cap on the scope and secure it with steri strips.During the procedure, the cap came off and was not retrieved.The cap is expected to pass naturally through the gastrointestinal (gl) tract without additional intervention.There were no reports of patient harm.
Additional Manufacturer Narrative
Updated fields: d10, h2, h3, h6, and h11.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection.Based on the results of the investigation, a likely cause of the malfunction identified failure to follow instructions.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21780181
• Report Number: 9614641-2025-00451
• Device Sequence Number: 8829376
• Product Code: FDS
• UDI-Device Identifier: 04953170278297
• UDI-Public: 04953170278297
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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 Model Number: D-201-12704
• Device Lot Number: 3XK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-1TH190 EVIS EXERA III GASTROINTESTINAL VIDEOSC
• Patient Sex: Unknown