MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON BILIARY STENT; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G21708
Medical Device Problem Codes	Dent in Material (2526); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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
When the nurse used the straightener to straighten the stent, the stent was kink.
Additional Manufacturer Narrative
Device evaluation: 01 x zso-7-12 device of lot number c2277381 involved in this complaint was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing record review: prior to distribution all zso-7-12 devices are subjected to a visual inspection and functional checks to ensure device integrity.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2277381.A review of the manufacturing records for zso-7-12 of lot number c2277381 did not reveal any discrepancies that could have contributed to this complaint issue.Review of historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the instructions for use, ifu0045 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ the precautions section of the instructions for use also states: "care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking of the stent." there is no evidence to suggest that the customer did not follow the instructions for use (ifu0045).Image review: an image was not returned for evaluation.Root cause analysis: definitive root cause could not be determined.A possible root cause could be attributed to the device kinking while being straightened by the pigtail straightener.It is possible this occurred due to the stent being subjected to uneven or excessive force during the straightening procedure, potentially due to technique or handling variability.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary: the user reported an issue with 1 unit of lot c2277381 of zso-7-12 device.When the nurse used the straightener to straighten the stent, the stent was kink.Confirmed quantity of 1 device, confirmed prior to use.Investigation findings conclude that a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the device kinking while being straightened by the pigtail straightener.It is possible this occurred due to the stent being subjected to uneven or excessive force during the straightening procedure, potentially due to technique or handling variability.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence as it was noted prior to patient contact.Complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 23-oct-2025.

• Brand Name: ZIMMON BILIARY 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 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23118962
• Report Number: 3001845648-2025-00484
• Device Sequence Number: 20693490
• Product Code: FGE
• UDI-Device Identifier: 00827002217089
• UDI-Public: (01)00827002217089(17)280313(10)C2277381
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K851962
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: G21708
• Device Catalogue Number: ZSO-7-12
• Device Lot Number: C2277381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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
• Patient Sex: Unknown