MAUDE Adverse Event Report: COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number	NTSE-022115-UDH-MB
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a nephrolithotripsy, the basket of the ncircle tipless stone extractor didn't´t open.A new extractor was used to finish the procedure.No adverse events have been reported as a result of the alleged malfunction.
Event or Problem Description
Additional information was received on 19jul2018.It was reported the ncircle tipless stone extractor was tested prior to use and the issue identified prior to patient contact.
Additional Manufacturer Narrative
H6 ¿ conclusions code: cause not established (4315).Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The device was returned with the handle between the open and closed position.A visual examination noted the basket formation is in the closed position.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 1.4 cm in length.A functional test determined the handle does not actuate the basket formation.A visual examination noted the basket sheath has pulled away from the support sheath and the sheaths are detached.There is a 5mm gap between the sheaths.The basket sheath is bent at 1 cm and 3 cm from the distal tip.A review of the device history record found no non-conformances associated with the complaint device lot numbers 8362240 or 8362240x.A search of complaint records revealed this is the only complaint against lot number 8362240x and there are no complaints associated with lot number 8362240.According to the instructions for use (ifu), precaution section: enclose the device in the sheath before removing from the tray/holder.Do not use excessive force to manipulate this device.Damage to the device may occur.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint device was found to have a basket that was closed and could not be opened due to sheath damage.The sheath was damaged and separated near the handle, preventing the basket from functioning.All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open.The condition of the returned device makes it possible that it was inadvertently damaged during handling / use.Since no information related to product handling is available, a definitive cause could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7689680
• Report Number: 1820334-2018-02139
• Device Sequence Number: 805267
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)201109(10)8362240X
• 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: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2018

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 Expiration Date: 11/09/2020
• Device Catalogue Number: NTSE-022115-UDH-MB
• Device Lot Number: 8362240X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 09/05/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/08/2018; 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1