MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G25379
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Unable to advance the device through the duodenoscopy.A new oacl-10-5 was opened and used without issue.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6); cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).1 x oacl-10-5 of lot number c1450022 was not returned to cirl for an evaluation.Therefore a limited documentation based investigation was completed.As the device of rpn: oacl-10-5 of lot number c1450055 was not returned to cirl for a lab evaluation.The complaint is confirmed based on the customer¿s testimony.A possible root cause for this complaint may be due to the stent receiving excessive force during the procedure this may have attributed to the device becoming stuck in the endoscope; however as operational conditions are unknown this cannot be conclusively determined as a contributory factor.A review of the manufacturing records for the device of lot # c1450022 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1450022 upon review of complaints this failure mode has not occurred previously with this lot # c1450022.Prior to distribution, all oacl-10-5 devices are subject to visual inspection and functional checks to ensure device integrity.There is also a visual inspection of the product and packaging at packaging, packaging quality control, and post sterile quality control.It should be noted that as per the instructions for use which accompanies this device the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use.¿ also the instruction for use, in step 3 the user is instructed to ¿ with the elevator open, advance device in short increments under endoscopically visualized exiting scope.Note: as front flap of stent enters accessory channel, keep positioning sleeve over back flap until completely in accessory channel.Slide positioning sleeve over pushing catheter, keeping it clear of accessory channel.¿ despite numerous attempts for additional information, only limited information was returned on 11th of february 2018, that another oacl-10-5 was used to complete the procedure and the device in question was not modified by the user.Therefore, no further details were received on the event to help determine a definite root cause to this complaint.The complaint is confirmed based on customer testimony.The patient didn¿t experience any adverse as result of the device failure and based on the information provided.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement.¿ unable to advance the device through the duodenoscopy.A new oacl-10-5 was opened and used without issue.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement.¿ unable to advance the device through the duodenoscopy.A new oacl-10-5 was opened and used without issue.

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8179180
• Report Number: 3001845648-2018-00604
• Device Sequence Number: 16549402
• Product Code: FGE
• UDI-Device Identifier: 00827002253797
• UDI-Public: (01)00827002253797(17)210205(10)C1450022
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2019

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 Expiration Date: 02/05/2021
• Device Model Number: G25379
• Device Catalogue Number: OACL-10-5
• Device Lot Number: C1450022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 11/26/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/16/2019; 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1