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

Model Number	MAJ-2315
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
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
1 of 2.It was reported that during a therapeutic ercp (endoscopic retrograde cholangiopancreatography), the distal cover of the duodenovideoscope dislodged inside the patient¿s body.The scope was reinserted and the cap was retrieved.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection.As the returned device was used, a representative device was used to attempt to reproduce the reported event.When correctly attached to the endoscope, deformation of the top and bottom sections of the representative device was confirmed and the reported event could not be reproduced.The top and bottom of the returned used distal cover were not deformed, which indicated the distal cover may have not been properly attached to the endoscope.In addition, the following reportable malfunctions were identified during the device evaluation: crack at bottom of distal cover.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the reported malfunction: the distal end cover was not properly attached and dropped off due to the load during the procedure.It is likely the following led to the investigation finding of a cracked base: cracks may have formed due to stress loading from incorrect distal cover installation and the influence of certain chemicals.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the 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: 24126932
• Report Number: 3003637092-2026-00011
• Device Sequence Number: 5457251
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Device Lot Number: H5725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q190V
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown