MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BILIARY STENT V

Model Number	PBD-V621R-1007
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	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following patient identifiers: (b)(6).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 endoscopic retrograde cholangiopancreatography (ercp), a small plastic-like fragment fell out into the patient¿s body when a non-olympus guidewire was passed through the duodenovideoscope.The fragment, unable to be confirmed as the distal end cover or a fragment of the single use biliary stent, was retrieved with biopsy forceps and the procedure was completed with a backup device.There were no reports of patient harm.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.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.However, during evaluation of results on related endoscope investigation, which are combination devices, the following was found: the foreign material sent was analyzed and found to be part of the channel of the forceps that had been scraped.Therefore, it was determined there was no problem with the single use biliary stent.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BILIARY STENT V
• Common Device Name: SINGLE USE BILIARY STENT
• 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: 21645148
• Report Number: 9614641-2025-00339
• Device Sequence Number: 7662375
• Product Code: FGE
• UDI-Device Identifier: 04953170185199
• UDI-Public: 04953170185199
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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-V621R-1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-2315.; TJF-Q290V.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown