MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM

Model Number	G25380
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the initial reporter: "i received a product complaint on (b)(6) regarding our stent introducer in relation to a biliary procedure.According to the initial reporter, "during an ercp, the endoscopist and technician used a stent introducer to advance a plastic biliary stent into the working channel of a duodenoscope.Unknowingly, the stent introducer was advanced beyond the biopsy port and into the scope.Because the team were unaware of this, no attempt to retrieve the introducer was made.When the same scope was used for another procedure, it was discovered that the stent introducer was still inside the scope, and was advanced down and out of the scope by a new stent." it was further reporter that "the patient has not been affected by this event." additional information provided on 05nov2019, a duodenoscope was used during the procedure.

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9317284
• Report Number: 3005580113-2019-00752
• Device Sequence Number: 19460296
• Product Code: FGE
• UDI-Device Identifier: 00827002253803
• UDI-Public: (01)00827002253803(17)220708(10)C1629388
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2019
• Report Date (Section F): 11/13/2019

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 Expiration Date: 07/08/2022
• Device Model Number: G25380
• Device Catalogue Number: OACL-10-7
• Device Lot Number: C1629388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/05/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 11/13/2019