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	03/02/2026
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
It was reported that during a therapeutic ercp procedure, the distal cover dislodged.The distal cover was removed as a foreign body from the patient's airway.The patient's condition is reported as stable.Further follow-up had been conducted and is currently pending for additional information.This report is 2 of 2.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields- b5, h2, h3, h4, h6, h7, h9 and h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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 and the event could not be confirmed.However, it is likely cause of failure was due to the following mechanism.The distal end cover was not properly attached and dropped off due to the load during the procedure.Since it is difficult to visually detect the state of attachment of this product, it is feasible that the attachment of the distal cover was insufficient.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information received identified the procedure was a endoscopic retrograde cholangiopancreatography for investigation of stones in the bile duct and removal of stents.The distal cap had to be removed as a foreign body from the airway requiring airway support.Additionally the cover was dislodged in the mouth or throat and removed manually or via the endoscope using grasping forceps.The procedure was completed, but with a 10-minute delay and extension of sedation time, requiring re-insertion of the scope to locate and retrieve the missing distal cover and to stabilize the airway.
Additional Manufacturer Narrative
This supplemental report is being submitted for a correction to the b5 event details updated field- h4.Correction- b5.
Event or Problem Description
Additional information received identified that the no reinsertion of scope was required.This device was in the airway and not mouth/throat, and was removed using the endoscope and grasping forceps.

• 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: 24746485
• Report Number: 3003637092-2026-00068
• Device Sequence Number: 8772662
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K253646
• 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,Followup
• Report Date (Section B): 05/23/2026

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: H5602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/07/2026; 05/20/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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-Q290V DUODENOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown