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

Catalog Number NTSE-015115

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: exempt pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that while preparing to perform a trans-ureteral lithotripsy (tul) followed by stone removal using a ncircle tipless stone extractor, the physician tested the basket movement prior to starting by retracting the basket into the sheath then attempting to open the basket, however the basket did not open well.A second basket was opened and the procedure was completed successfully with no reported adverse effects to the patient as a result of this alleged product malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the device lot number is 9181318.The complaint device was returned with the handle and the basket formation in the opened position.The male luer lock adapter (mlla) is finger tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.8 cm in length.Visual examination noted that one wire in the basket formation has pulled out of the distal cannula.Functional testing determined the handle actuates the basket formation to the opened and closed positions.A review of the device history record found there were no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history records revealed there have been no other complaints received for the complaint device lot number 9181318.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.Investigation of the returned device found it had a broken basket wire.It is possible the information provided by the user that the basket did not open well was referring to the shape of the basket and not the functioning of the device.The complaint device was found to have a basket where one wire had pulled out of the cannula that holds the proximal wires of the basket together.Measures have been initiated to address this failure mode.It has been determined that the basket subassembly, which is manufactured by a supplier, was not being pull tested properly by the supplier.The testing process used by the supplier is being changed to correct the issue.The corrections were not yet in place at the time this device was manufactured.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 Description

There has been no new information received since the last report was submitted.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8164831
• MDR Text Key: 130501383
• Report Number: 1820334-2018-03677
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)210921(10)9181318
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9181318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1