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	01/28/2026
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 a therapeutic endoscopic retrograde cholangiopancreatography (ercp) was done on a patient who had a metal stent that was obstructed by a wall of stones.The customer tried to remove the stones and get through with multiple instruments, which caused some bleeding.When the scope was removed, the single use distal cover was not on the duodenovideoscope.The distal cover could not be found when they went back in.The patient was hospitalized and later coughed up the distal cover in one piece.Additional information received from the customer indicated the patient had been hospitalized for elevated liver enzymes for seven days.The patient was discharged on (b)(6) 2026.The customer indicated the distal cover may have scraped the patient when it came off the scope which may have contributed to mild bleeding.The patient remained hemodynamically stable and did not require any intervention for the bleeding.The customer indicated they did not go back into the patient to look for the distal cover as the doctor stated the patient would pass it naturally.The patient later coughed up the distal attachment in recovery.There were no reports of patient harm.This is report 2 of 2.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: h2, h6, h11.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.The event can be prevented by following the instructions for use which state: "warning: detach the distal cover from the distal end of the endoscope when the distal cover cannot be attached to the endoscope smoothly or any incorrect attaching procedure is noticed.Refer to section 9.5, "detach the distal cover" for detaching the distal cover.With a new distal cover, repeat step 1 through 4.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed." should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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: 24421823
• Report Number: 3003637092-2026-00037
• Device Sequence Number: 5917128
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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
• Device Lot Number: H5702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q190V DUODENOVIDEOSCOPE (SN (B)(6))
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 110 KG