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

Catalog Number NCT4-024115

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, the basket of a ncompass nitinol tipless stone extractor failed to open or close properly.No adverse effects have been reported due to the occurrence.The user facility stated that no further information about the event is available.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, the basket of a ncompass nitinol tipless stone extractor failed to open or close properly.No adverse effects have been reported due to the occurrence.The user facility stated that no further information about the event is available.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 ncompass nitinol tipless stone extractor was returned for investigation with the handle in the open position and the basket formation partially open.5 mm of the basket formation was protruding the distal tip.A functional test determined the handle did not actuate basket formation.The support sheath was severed at the nose of the mlla (male luer lock adaptor).The cannulated handle was bent.The support sheath was adhered to the basket sheath.When pulling on the support sheath alone, back and forth, the basket did move but when retracted the basket wires caught on the sheath.A review of the device history record found one non-conformance related to sheath, buckling.The issue of sheath buckling when the function of the basket was tested during the quality inspection may have been related to the complaint issue.However, all devices from the lot were tested for proper functionality during the quality inspection, and all devices that were shipped passed the testing.A review of complaint history records shows one other complaint associated with the complaint device lot reported the same issue from the same customer (manufacturer reference # 1820334-2021-01026).Although the dhr review found a related non-nonconformance and a related complaint for the lot, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.There was not sufficient evidence to conclude 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% 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: 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 was non-functional due to extensive sheath damage.The yellow support sheath and basket sheath were both separated at the handle, preventing the basket from being opened or closed.There was not enough evidence available to make a determination of the cause of the issue.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.

• Brand Name: NCOMPASS NITINOL 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: 11574625
• MDR Text Key: 244414593
• Report Number: 1820334-2021-01020
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002327013
• UDI-Public: (01)10827002327013(17)240113(10)13686864
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Catalogue Number: NCT4-024115
• Device Lot Number: 13686864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1