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

Catalog Number NTSE-022115-UDH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/06/2018

Event Type  Injury  

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 on (b)(6) 2018, the ncircle tipless stone extractor ((b)(4)) was used for a procedure and a ureteral injury was confirmed after/during a procedure.It is unknown exactly what caused the injury.Additional information was received on (b)(6) 2018 in response to follow up for additional event information.Degree of injury and how it occurred are not known yet.It seems that the doctor doesn't think the (b)(4) caused the injury or had a breakage or defect.However he wants cook the manufacturer to investigate the device in question to see there is a breakage or defect.Additional information was received on (b)(6) 2018, in response to manufacturer's request for other devices/medications used during the procedure.As reported, a rigid ureteroscope (maker and model unknown), a laser fiber (lumenis¿ slimline fiber) and some guide wires should have been used.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Conclusions code: cause cannot be traced to device (4310).Investigation ¿ evaluation a visual inspection and functional testing of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, and device specifications.One device was returned for investigation.The device was returned with the handle and basket formation in the closed position.The collet knob is tight and secure.The male luer lock adapter (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A visual examination noted the support sheath is bowed in appearance.A kink was noted in the basket sheath approximately 1 cm from the distal tip.A functional test noted the handle actuates the basket formation.The basket wires were found to be secure.There was no breakage or defect noted.The device history record was reviewed and there were no related non-conformance's noted.A search of complaint records revealed this is the only related complaint associated with complaint lot number 8120417.According to the precaution section of the instructions for use (ifu) that accompanies this device: 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 kink in the sheath, but the kink did not affect device function, the basket was still able to open and close normally.A slight bend in the support sheath was also noted, but also did not affect device function.No damage or issues with the returned device were found that could have caused a ureteral injury during use.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: 7762624
• MDR Text Key: 116420114
• Report Number: 1820334-2018-02438
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200807(10)8120417
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 8120417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other