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

Model Number	MAJ-2315
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	11/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers (b)(6).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 distal end cover fell off during the procedure, most probably, when it was being pulled out.Once scope was removed it was confirmed there was no longer a cover on the distal end of the scope.The distal end cover was found in the stomach and recovered.There were no reports of patient harm.
Event or Problem Description
Upon follow up, the customer confirmed that no type of lubricants were applied to the distal cover of the endoscope when used with the patient.
Additional Manufacturer Narrative
Updated fields: b5, d9, h3, h6, h7, h9, h11.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned in damaged condition and did not meet specifications.The distal cover was found to be cracked on the bottom.The reported event was not confirmed; the top and bottom of the returned device was found to be undeformed, which means that the distal cover may have not been properly attached to the endoscope.However, there is no indication that this device was not used in accordance with the instructions for use/labeling, so the cause of this event at the user facility could not be determined.The returned device was already used, so the functional testing was performed using a representative device.During functional testing of the representative device, the top and bottom of the distal cover were found to be deformed, which means that the distal cover was properly attached to the endoscope.The distal cover has been verified to not drop off the endoscope when it is properly attached.As a result, no cracks occurred on the distal cover when it was attached to the endoscope.The distal cover has been verified not to break when it is properly attached.Based on the results of the investigation, it is likely the following led to the distal cover cracking: the connection between subject device and the endoscope became unstable, and the distal cover cracked due to increased stress while it is in use.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.
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.

• 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: 21031178
• Report Number: 3003637092-2024-01013
• Device Sequence Number: 15736457
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K220587
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

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: MAJ-2315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 08/18/2025; 09/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 09/09/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003637092-11/15/2023-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown