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

Catalog Number NGE-017115

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

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 Description

It was reported that one ncircle tipless stone extractor was kinked on the shaft.Two other extractors were used but were kinked on the tip (please refer to mdr #1820334-2018-01195).They were all difficult to close after kinking.The user had to use a fourth basket to successfully complete the procedure.The glass tip of both laser fibers broke off in the scope.They had to use a third fiber to successfully complete the procedure.(b)(4) - 2 ncircle tipless stone extractor - mdr #1820334-2018-01195, (b)(4) - 1 ncircle tipless stone extractor - mdr #1820334-2018-01196, (b)(4) - 2 cook® single-use holmium laser fiber - mdr# 1820334-2018- 01197.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

Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of 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 and the basket formation in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett measures 3.5 cm.A visual examination noted kinks in the basket sheath located at 86.5 cm and 87.5 cm from the distal tip.A functional test noted the handle does not actuate the basket formation.The handle was disassembled.The basket formation could not be manually actuated.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 complaint device lot number.As documented in the instructions for use (ifu): caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.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 would not properly open/close due to sheath damage.The sheath of the device was found to have kinks along its length.Based on the nature of the kinks, it appears there were issues attempting to insert the devices into the scope during the procedure.The two ncircle tipless stone extractors (mfr.Report # 1820334-2018-01195) also used during the same procedure had similar kinks in the sheaths.Three devices with similar damage during the same procedure indicates there was possibly an issue with the scope that made insertion of the sheaths difficult.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 Description

Event occurred during a ureteroscopy with laser lithotripsy procedure.Pr224445 - 1 ngage nitinol stone extractor ¿ mdr #1820334-2018-01196.

• Brand Name: NGAGE NITINOL 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: 7480847
• MDR Text Key: 107245843
• Report Number: 1820334-2018-01196
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR