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

Model Number	G21803
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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
During an initial examination, the prosthesis cover became lodged in the endoscope (not detected at the time of the examination).Despite careful handling in the endoscope processing area, the agents did not detect its presence in the endoscope (swabbing done normally, passing through the machine without error).During the next examination, the stent protector was released into the patient's body; the endoscopy nurses noticed it immediately and it was able to be removed.Describe the object and how it was retrieved = not removed from the patient but from the endoscope.1.Please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Ans.Stored away from light, at room temperature in a room designated for medical devices.2.What is the reorder number, diameter and length of the wire guide that was used with this device in this procedure? ans.Olympus wire 0.25 and 450 cm.3.Was the wire guide lubricated prior to use? ans.Yes with phy serum.4.Was the wire guide inspected for damage prior to use? ans.Yes inspected, no damage.5.Was the device at the centre of the complaint inspected for damage prior to use? ans.Yes inspected, no damage.6.Were previous procedures i.E., sphincterotomy etc.Carried out prior to placing the complaint device? ans.Yes biliary sphincterotomy before.7.Did the patient involved exhibit altered anatomy or tortuous anatomy? ans.No.8.What intervention (if any) was required? ans.Ras.9.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? ans.No second procedure was performed following the erroneous insertion of the black adapter.10.What is the endoscope manufacturer, the model number and working channel size that was used for the procedure? ans.Fujinon duodeno ed 530 xt 8.11.Does your medical facility have a service/maintenance schedule associated with its endoscopes? ans.Yes.12.Was resistance encountered when advancing the wire guide to the target location? ans.No.13.Was resistance encountered when advancing the introduction system in place to the target location? ans.No.How did the physician deal with this resistance? ans.No relation to the subject of the complaint.14.How did the physician determine the length of the stent to be used for the procedure? ans.No relation to the subject of the complaint.15.Where was the stricture located in the duct? ans.No relation to the subject of the complaint.16.Was the stricture dilated prior to placing the device? (if so, please indicate what device(s) were used.) ans.Implantation of a stent as a preventative measure against pancreatitis.17.Was resistance encountered when advancing the stent through the obstructed area? ans.No relation to the subject of the complaint.18.Were any modifications made to the complaint device or accessories used with the device in this procedure? (e.G., guiding catheter shortened, stent cut etc.) n/a, yes.No (if yes, please indicate what modifications were made:) ans.No.20.Did the patient require any additional procedures as a result of this event? ans.No.21.What intervention (if any) was required? ans.Ras.

• Brand Name: GEENEN PANCREATIC STENT SET
• 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: 24743366
• Report Number: 3001845648-2026-00110
• Device Sequence Number: 9230384
• Product Code: FGE
• UDI-Device Identifier: 00827002218031
• UDI-Public: (01)00827002218031(17)280818(10)C2333930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K900923
• 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): 05/19/2026

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: G21803
• Device Catalogue Number: GPDS-5-5
• Device Lot Number: C2333930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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