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

Catalog Number NGE-017115

Device Problem Difficult to Open or Close (2921)

Patient Problems Autoimmune Disorder (1732); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  malfunction  

Event Description

As reported, an ngage nitinol stone extractor would not open or close when testing the device prior to use.Additional event information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k) # 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

Information was available but inadvertently omitted from the previous medwatch report: the procedure being performed was a stone retrieval.The case was able to be completed without the device, but it was not specified how the case was completed.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: h6: component code (annex g) event description: as reported, during a stone retrieval procedure, an ngage nitinol stone extractor would not open or close when testing the device prior to use.The case was able to be completed without the device, but it was not specified how the case was completed.No adverse events have been reported as a result of the alleged malfunction.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 ngage nitinol stone extractor was returned for investigation in an open, labeled package.Inspection of the returned device noted: the device was returned with the basket formation in the closed position and protruding from the basket sheath.The mlla [male luer lock adapter] was loose.There was a severe bend in the basket sheath, approximately 50 centimeters from the cannula.There was a slight curve noted at the support sheath.A functional test determined the handle did not actuate basket formation.The handle was disassembled.The basket formation could not be manually actuated.The basket was removed from the basket sheath, it would not form a complete basket.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.There is no evidence to support that the device was manufactured out of specification.A review of relevant manufacturing and quality control documents was conducted.All extractors are inspected for damage and 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: suggested handling instructions for extractors and forceps important: excessive force could damage device.The returned device was found to nonfunctional due to sheath damage.The basket sheath was kinked approximately halfway along its length.The kink was preventing the basket assembly from moving freely within the sheath.The cause for the damage is unknown.Excessive force may have been inadvertently applied to the device, however, no information is 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.

Event Description

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

• 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
• 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: 15073359
• MDR Text Key: 304622615
• Report Number: 1820334-2022-01241
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)250525(10)14751230
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115
• Device Lot Number: 14751230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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