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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a flexible ureteroscopy using a ncircle tipless stone extractor, the basket could not be opened.The device was tested prior to use.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event description: as reported, during a flexible ureteroscopy using a ncircle tipless stone extractor, the basket could not be opened.The device was tested prior to use.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu), and quality control data.One ncircle tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle in the open position and the basket formation in the closed position, with one wire protruding the distal tip of the basket sheath.The mlla [male luer lock adapter] was tight.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 2.7 cm in length.The support sheath was bowed.The cannulated handle was protruding outside the nose of the mlla for a length of 1.9 cm.The protruded cannulated handle was kinked.The cannulated handle was detached from the coil assembly upon actuation test, the basket sheath broke from the cannulated handle.The remaining basket formation appeared to be inside the basket sheath.The basket sheath appeared to be smashed at the distal portion of the support sheath.The cannulated handle appeared to have separated at the junction of the coil assembly.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents was conducted.All extractors are 100% verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to have a basket that was closed and could not be opened due to damage.The sheath was severely kinked at the handle.The basket sheath and purple support sheath were both kinked to 90 degrees at the handle, preventing the basket from functioning.It was also observed that 1 of the 4 basket wires was broken.All basket devices are inspected for functionality and damage during manufacturing and quality control checks.The basket would not function due to sheath damage.The cause of the sheath damage could not be determined.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.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.

Event Description

There is no new patient or event information to report.

• 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: 10871574
• MDR Text Key: 223770920
• Report Number: 1820334-2020-02165
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)230831(10)13399077
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 13399077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1