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

Catalog Number NTSED-024115-UDH

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

It was reported that a ncircle delta wire tipless stone extractor was kinked [near yellow end] and it was not possible to close the extractor.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

Customer postal code: (b)(6).Initial reporter occupation = unknown.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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 09jun2022 and 10jun2022: no event date is known, as the device problem was noted three times over the course of a month.Each time, the doctor tested the device prior to use and noted the device was kinked and unable to close, the device was never used on a patient.No difficulty was reported when pulling the device from the package, it was reported that the device was already kinked prior to removal from packaging.Each procedure was completed using a new device.A section of the device did not remain inside the patient(s) body.The patient(s) did not require any additional intervention due to this occurrence.The patient(s) did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

The reported device problem was noted a few times over the course of a month.Reference this report and mdr # 1820334-2022-01010.

Manufacturer Narrative

Corrected information: b5, h6: component code (annex g).Event description: as reported, a ncircle delta wire tipless stone extractor was kinked [near yellow end] and it was not possible to close the extractor.The reported device problem was noted a few times over the course of a month.Reference this report and mdr # 1820334-2022-01010.Event dates are unknown.The device was tested prior to use and found to be kinked and unable to close.The device was never used on a patient.No difficulty was reported when pulling the device from the package.It was reported that the device was already kinked prior to removal from packaging.The procedure was completed using a new device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to due to this occurrence.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 procedures.One ncircle delta wire tipless stone extractor was returned for investigation in open packaging without its packaging tray.The device was returned with the handle in the closed position, with approximately 2mm of the basket assembly protruding from end of the basket sheath.The basket sheath was bent near the yellow support sheath.The handle actuated the basket assembly, but the basket assembly does not fully withdraw into sheath.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 inspected for damage and are verified to assure the basket opens and closes properly.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: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to be nonfunctional due to sheath damage.The cause for the damage is unknown.Excessive force may have been inadvertently applied to the device, but no information was known regarding device handling.Therefore, the cause of the issue could not be conclusively determined.Per the quality engineering risk assessment, no further action is 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.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14631470
• MDR Text Key: 301634020
• Report Number: 1820334-2022-01011
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)250225(10)14560279
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSED-024115-UDH
• Device Lot Number: 14560279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1