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

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes relevant information known at this time. a follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that the plastic from the fanelli laparoscopic endobiliary stent set had chipped off in several places inside the sterile packaging of the product.This was discovered prior to the use of the product on a patient; accordingly, no patient adverse events resulted from the product issue.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu) manufacturing instructions, quality control data, specifications, and visual inspection of the device was conducted during the investigation.A visual examination of the returned devices confirmed the report.The white plastic stents are broken and brittle to the touch.There are loose pieces of the stents inside the inner white sleeves.Note: each stent and loading catheter is placed inside a white sleeve with a clear side inside the sealed pouches.The introducers also have a kink in them, possibly from a rubber band around the packaging when received here for evaluation.Based on the provided finished device lot #s, the raw material lot # for the tubing was determined.There was some quantity of the specific raw material lot in house.A review of this raw material lot identified it was stored in a uv protected packaged as required by the raw material requirements.A visual and tactile evaluation of the raw material identified it was not brittle like the returned devices.The raw material tubing was as expected.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events.It should be noted there were no other reported complaints for this lot number.All devices from the same lot have been distributed with no additional complaints from the same c-fbss-100 lot or fbs-7.0-35-6.0 component lots.Per ifu c_t_fbss_rev1, ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ it was confirmed the c-fbss-100 devices are not protected from fluorescent light during storage at the customer facility.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.This failure mode has been escalated per internal processes.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7197443
• Report Number: 1820334-2018-00007
• Device Sequence Number: 73174
• Product Code: FGE
• UDI-Device Identifier: 00827002136991
• UDI-Public: (01)00827002136991(17)180620(10)5972808
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K010601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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?: Yes
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1