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

Catalog Number NTSED-024115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Customer name and address and phone - postal code: (b)(6).Pma/510(k) number = 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, during an unspecified procedure, the ncircle delta wire tipless stone extractor would not close properly.A new device was opened and the procedure was completed.No adverse events have been reported as a result of the alleged malfunction.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

Additional information was received on 19jul2021: the type of procedure being performed was a ureteroscopy/extraction de calcul renal.No part of the device was separated.The device was tested prior to use, and was uncoiled during testing.A second device was opened to complete the procedure.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: it was reported, during a ureteroscopy/kidney stone extraction procedure, the ncircle delta wire tipless stone extractor would not close properly.A second device was opened and the procedure was completed.The patient reportedly experienced no harm as a result of the issue.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 (dhr), manufacturing instructions, the instructions for use (ifu), and quality control data.One ncircle delta wire tipless stone extractor was returned in an open package for investigation.Inspection of the returned device noted: the mlla [male luer lock adapter] was tight.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.0 cm in length.The support sheath was bowed in appearance.One wire in the basket formation was broken.A functional test determined the handle did actuate basket formation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents was conducted.All extractors are 100% inspected for damage.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.The returned device was found to have a basket that had 1 broken wire, preventing the basket from having the proper shape.The handle functioned properly, with the basket extending and retracting.The cause for the broken basket wire could not be determined.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel have been notified, and we will continue to monitor 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 is no new patient or event information to report.

• Brand Name: NCIRCLE DELTA WIRE 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: 12135541
• MDR Text Key: 265154813
• Report Number: 1820334-2021-01714
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)240212(10)13756814
• 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,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2024
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 13756814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR