MAUDE Adverse Event Report: COOK INC FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Codes	Bent (1059); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, it is feasible that shipping, handling, and/or storage may have contributed to the failure mode.However, without the benefit of visual, dimensional, and/or functional testing of the product, the root cause could not be conclusively determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that a fanelli laparoscopic endobiliary stent set was opened and taken off the delivery system.The device was bent and it fractured on the table prior to delivery.The event occurred prior to patient contact.

• Brand Name: FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6734662
• Report Number: 1820334-2017-02111
• Device Sequence Number: 881793
• Product Code: FGE
• UDI-Device Identifier: 00827002136991
• UDI-Public: (01)00827002136991(17)170401(10)4939992
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K010601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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: N/A
• Device Catalogue Number: C-FBSS-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1