MAUDE Adverse Event Report: Cook Ireland LTD ZILVER 635 BILIARY SELF EXPANDING METAL STENT; FGE, stents, drains and dilators for the biliary ducts

Model Number	G50622
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Through the endoscopic channel, the stent was guided along the acro wire guide to the common bile duct.After a long effort, it was unable to cross the stenosis area.User retracted the device from patient, it was found that the tip of the stent was bent and unusable.During the cleaning process, the stent was accidentally released, and the kink inside the stent were clearly visible.Successfully completed the procedure by changing to another same rpn device.

• Brand Name: ZILVER 635 BILIARY SELF EXPANDING METAL STENT
• Common Device Name: FGE, stents, drains and dilators for the biliary ducts
• Manufacturer (Section D): Cook Ireland LTD; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer (Section G): Cook Ireland LTD; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick V94 N-8X2 ; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 25358719
• Report Number: 3001845648-2026-00209
• Device Sequence Number: 15925748
• Product Code: FGE
• UDI-Device Identifier: 10827002506227
• UDI-Public: (01)10827002506227(17)280923(10)C2347269
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: G50622
• Device Catalogue Number: ZILBS-635-6-8
• Device Lot Number: C2347269
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK ACRO-35-450; OLYMPUS DUODENOSCOPY
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 149 LB