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

Catalog Number NTSE-022115-UDH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: 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 the ncircle tipless stone extractor basket tip broke during a ureteroscopy.The device was removed and a like device was used to complete the procedure as intended.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of drawings, the instructions for use, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open position and the basket formation in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is finger tight.The polyethylene terephthalate tubing (pett) measures 2.7 cm in length.A functional test determined the handle actuates the basket formation.A visual examination noted the wires on the basket formation near the knot are broken.The device history record was not able to be reviewed as the lot number of the complaint device was not known.A review of complaint history for the associated device lot could not be performed without the lot number of the complaint device.As documented in the instructions for use (ifu), precautions 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 broken basket wire, with the wire broken at the distal knot that holds the two basket wires together.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during use of the device.It is possible the wire was exposed to a laser, but the use of a laser during the procedure was not reported.It is also possible that stresses placed on the wire at the knot location caused the wire to break during use.Measures have been initiated to address this failure mode.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: 7369903
• MDR Text Key: 103456470
• Report Number: 1820334-2018-00797
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1