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

Catalog Number NGE-017115

Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510k #¿ exempt.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.

Event Description

As reported, during a ureteroscopy, three ngage nitinol stone extractor were unable to function properly.Two of the devices, the user found the distal end of the basket was detached on both devices.The third device, the distal basket wire detached, preventing the basket from opening and closing properly.A fourth same device was used to complete the procedure.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrections: h6 = annex a, annex g summary of event: as reported, during a ureteroscopy, three 'ngage nitinol stone extractors' were unable to function properly.Two of the devices, the user found the distal end of the basket was detached on both devices [device #2 / device #3].The third device, the distal basket wire detached, preventing the basket from opening and closing properly [device #1].A fourth same device was used to complete the procedure.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.A search of the device history record found no related non-conformances reported for lot.A complaint history database search showed five related complaints associated with the complaint device for lot.All were reported for the same issue.All devices are inspected for functionality, damage, and specifically the basket wires for spacing, during quality control checks.There is not sufficient evidence to conclude that the devices in the lot were non-conforming.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, it was concluded that there was no evidence that nonconforming product exists in house or in field.Cook has concluded that the device was manufactured to specification.Cook also reviewed product labeling.The ifu [t_shef_rev1] supplied with the device does not provide any information related to the reported issue.Functional tests and visual inspection of the three (3) returned complaint device(s) was also conducted.A device failure analysis was conducted on the returned device under ¿device #1¿.A visual inspection found the distal shrink tube was not holding the basket formation secure to the end of the basket sheath; this allowed the basket to move distally, exposing the proximal end of the basket wires.The cause for the issue could not be established.A device failure analysis was conducted on the returned device under ¿device #2¿.There was no issue with the basket of the device; the basket was not detached; the handle would not function the basket; the handle was disassembled and the basket could not be manually functioned using the cannulated handle.The cause for the issue could not be established.A device failure analysis was conducted on the returned device under ¿device #3¿.There was no issue with the basket of the device; the basket was not detached; the handle would not function the basket; the orange support sheath and basket sheath were detached; glue residue was observed on the basket sheath.The returned device was found to have a basket that would not open due to separation of the orange support sheath and basket sheath.Glue residue was observed on the basket sheath, indicating proper manufacturing.The cause for the issue could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

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: 17756151
• MDR Text Key: 323510759
• Report Number: 1820334-2023-01242
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260404(10)15370736
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 15370736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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