MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number	MAJ-2315
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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.This report is related to mfr #.
Event or Problem Description
It was reported a single use distal cover fell off the scope and was discovered in the patient¿s mouth during an endoscopic retrograde cholangiopancreatography.The cover was retrieved from the patients mouth and procedure was completed with no report of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to correct d4 - unique identifier (udi) number.Since the lot number is unknown at this time, the udi is either (b)(4) or (b)(4) depending on the lot number used.
Event or Problem Description
No additional information from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: h2, h6, and h11.The device was not returned to olympus for inspection.Consequently, the reported failure was not confirmed.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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: SINGLE USE DISTAL COVER
• Common Device Name: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21665812
• Report Number: 3003637092-2025-00051
• Device Sequence Number: 7625369
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K220587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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: MAJ-2315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 11/05/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/28/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q190V.
• Patient Sex: Unknown