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

Model Number	PBD-421-1007
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related patient identifiers: (b)(6).The device was returned to olympus for inspection.The olympus investigator was not able to confirm the customer failure.The investigation found that two of four flaps were deformed, but all flaps were attached to the stent.Based on the results of the investigation, the root cause could not be identified.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
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 on the stent were missing and had detached.There was no report of patient harm.This is report 4 of 4.

• 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: 24606535
• Report Number: 9614641-2026-00290
• Device Sequence Number: 9026367
• 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
• Report Date (Section B): 03/16/2026

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: PBD-421-1007
• Device Lot Number: 43K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/16/2026
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown