MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BILIARY DRAINAGE TUBE

Model Number	PBD-421-1007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2025
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
It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, when the biliary drainage tube was removed, it was determined that 3 of the 4 flaps were missing and had detached from the patient.The fourth flap detached during removal from the patient.The flaps were detached at the proximal end.The procedure was then completed.Additional information was requested but not available at this time.There were no further reports of patient harm.
Event or Problem Description
Additional information received that the drain was removed using a snare, and at the time of retrieval, only one flap remained attached to the drainage device.It was assumed that the all flaps had already passed through the intestines, reached the small bowel, and were naturally excreted, and no diagnostics were performed.The medical team then retrieved a second drain from which three flaps had also detached; this device remained secured by only one fragile flap and was at risk of internal dislocation.During retrieval of the second drain, the final remaining flap also tore off.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: b5, d8, d9, h2, h3, h6, and h11 the device was returned to olympus and the reported failure was confirmed.Upon visual inspection all four side flaps from the stent were torn and were missing.A root cause could not be identified.Based on the results of the investigation, it is likely cause of the complaint is cause not established, which is the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: BILIARY DRAINAGE TUBE
• Common Device Name: DRAINAGE TUBE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23750830
• Report Number: 9614641-2025-02027
• Device Sequence Number: 14928671
• Product Code: FGE
• UDI-Device Identifier: 04953170046940
• UDI-Public: 04953170046940
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K933200
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: PBD-421-1007
• Device Lot Number: 43K
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Patient Sex: Unknown