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

Catalog Number NGE-017115-MB

Device Problem Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

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, during a transurethral lithotripsy using a ngage nitinol stone extractor, the user advanced the device, but the basket was unable to be closed completely.Another same type of device was used, but the same issue occurred.A different manufacturer's similar type device was used to successfully complete the procedure.The devices were tested prior to use.There were no issues with the patient's anatomy that would have prevented the device from opening/closing.No section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were report due to the alleged malfunction.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary: as reported, during a transurethral lithotripsy using a ngage nitinol stone extractor, the user advanced the device, but the basket was unable to be closed completely.Another same type of device was used, but the same issue occurred.A different manufacturer's similar type device was used to successfully complete the procedure.The devices were tested prior to use.There were no issues with the patient's anatomy that would have prevented the device from opening/closing.No section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were report due to the alleged malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.Two ngage nitinol stone extractors were returned for investigation.The first device was returned with the handle and basket formation in the closed position.The male luer lock adapter was tight, and the collet knob was tight and secure.The polyethylene terephthalate tubing measured 4.3cm in length.The basket measured 114.4cm in length.A function test determined the handle actuated the basket formation.When the handle was in the open position, approximately 1.5cm of cannulated handle protruded beyond the collet knob.The second device was returned with the handle in the closed position and basket formation in the open position.The male luer lock adapter was loose, and the collet knob was tight and secure.The polyethylene terephthalate tubing measured 4.3cm in length.The basket measured 114.4cm in length.A function test determined the handle did not actuate the basket formation.When the handle was disassembled, the basket formation could be manually actuated.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿excessive force could damage device.¿ based on the available information, cook has concluded that a cause for this event could not be determined.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

• Brand Name: NGAGE NITINOL 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: 11329888
• MDR Text Key: 232564267
• Report Number: 1820334-2021-00331
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482958
• UDI-Public: (01)10827002482958(17)231029(10)13522607
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 13522607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1