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

Catalog Number NTSE-045065-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

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 during a cystoscopy procedure, the user opened the package and checked the integrity of the device by opening and closing the basket.While testing the ncircle tipless stone extractor the user found the basket could not be closed.As second ncircle tipless stone extractor was opened and the user needed to use extra force to open and close the basket which caused difficulty to catch the stone.The user withdrew the device from the patient and use a third device to complete the procedure.As reported, the patient did not require any additional procedures and the patient did not experience any adverse effect due to this occurrence.The first basket failure reported in mfr report # 1820334-2018-03809.The second basket (hard to open and close) is being reported in this mfr report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: 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, the instructions for use, manufacturing instructions, and quality control data.One device returned to manufacturer for investigation.Returned packaging confirms lot number 9008930.The device was returned with the handle in the open position and the basket formation in the closed position.The male luer lock adapter (mlla) is loose.The collet knob is tight and secure.Visual examination noted the basket sheath is completely severed 5mm from the nose of the mlla.The portion of the support sheath still attached to the mlla is split.The point of separation appears to be stressed and pulled to separation.The basket formation is intact.A review of the device history record found there were no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history records shows that one other complaint was received on the complaint device lot # 9008930 from the same customer during the same procedure.The other complaint was not confirmed as the returned device was found to function normally.The instructions for use (ifu) contains the following precautions: 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.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 was closed and could not be opened due to sheath damage.The sheath was split and separated near the handle, preventing the basket from functioning.All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open.The condition of the returned device makes it likely that it was inadvertently damaged during handling / use.The investigation conclusion is cause traced to user; unintended use error caused or contributed to event.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

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

• 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: 8195556
• MDR Text Key: 131377062
• Report Number: 1820334-2018-03792
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002175204
• UDI-Public: (01)00827002175204(17)210711(10)9008930
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Catalogue Number: NTSE-045065-UDH
• Device Lot Number: 9008930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR