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

Catalog Number NTSE-015115

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

The customer has previously reported that during a ureteroscopy using a cook ncircle tipless stone extractor for a stone retrieval procedure, when the basket was tightened around the stone, the shaft's end split and opened up so that when it was reintroduced into the unspecified scope, the scope broke.It was reported that they have had 5 scopes breaking like this when using the ncircle device.As these 5 events had not been previously been reported to cook, this complaint was opened and filed to capture that information.The area representative stated that these incidents weren¿t reported to cook previously, because the customer was not certain of the reason for the breakages when they first occurred.The procedures were done by junior residents and initially it was thought that the reason for scope breakage was due to misuse of the scope.It is unknown what the lots are at this time, nor if the devices are available for return.No adverse events have been reported as a result of the alleged malfunction.Additional product, event, and patient information has been requested.At the time of this report, no further information has been provided.

Manufacturer Narrative

The lot number of the complaint device was received on 05feb2019.Additional information provided in: blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One stone extractor was returned to manufacturer for investigation.Returned packaging indicated the complaint lot number as 9260673.The device was returned with the handle between the open and closed positions.The basket formation was in the partially opened position.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.Visual examination notes a slight kink in the basket sheath approximately 1 mm from the distal tip.Functional testing determined the handle actuates the basket formation.The device functioned as intended.A review of the device history record for lot # 9260673 found there were no non-conformances.A review of complaint history records shows there are no other complaints that have been associated with the complaint device lot number 9260673.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 be functional, with the basket opening and closing as the handle was functioned.There was damage noted to the distal end of the sheath.There was a kink 1mm from the tip, and the tip has a flared appearance.This does match the event information that the end of the device was deformed from grasping stones.It appears likely too much force was applied in capturing the stones, damaging the end of the sheath.The ifu contains cautions about using excessive force when manipulating the device.Conclusion is cause traced to user; unintended use error caused or contributed to the 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

No new event 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: 8223722
• MDR Text Key: 132360533
• Report Number: 1820334-2019-00040
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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: 10/25/2021
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9260673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1