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

Catalog Number NTSE-022115-UDH

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.(b)(4).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, during a ureteroscopy, the wires at the end of the ncircle tipless stone extractor basket were collapsing on themselves while in the open position.They would not hold their shape.The procedure was successfully completed with another device of the same type.No adverse events have been reported as a result of the alleged malfunction.

Event Description

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

Manufacturer Narrative

H6: evaluation conclusion code: cause not established (4315).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, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The device was returned with the handle and the basket formation in the open positions.The collet knob is tight and secure.The male luer lock adapter (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 3 cm in length.A functional test determined the handle actuates the basket formation.A visual examination noted the basket formation is flattened and the basket wires appear to be crossed.A review of the device history record found there were no non-conformances related to the reported failure.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 8890160.As found in 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.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.All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open.The ifu contains cautions about manipulating the device to prevent damage.The complaint device was found to have a basket that was deformed.The wires that make up the basket were flattened.The condition of the returned device makes it possible that it was inadvertently damaged during handling / use.A conclusion as to the definitive cause for the basket deformation could not be established with the information available.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.

• 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: 7906002
• MDR Text Key: 121716929
• Report Number: 1820334-2018-02829
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002143357
• UDI-Public: (01)00827002143357(17)210517(10)8890160
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 8890160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STORTZ FLEX X, 3.6 FR