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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

It was reported that two ngage nitinol stone extractors failed to open.This report addresses one of the devices.The other device is reported under patient identifier #(b)(6).It was said that the devices opened at first during the procedure, but then failed to open again later in the procedure.The physician used another manufacturer's device to complete the procedure.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

E1- customer (person): postal code: (b)(6).E3- occupation: theatre manager.G4- 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, 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, unavailable, or unchanged.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 or that a death or serious injury occurred; nor is it admission 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

It was reported in additional information, both complaint devices were from the same lot number and used during the same procedure.Both device failures will be addressed under this complaint file, and the related complaint file (reference # (b)(4) ) will be closed as the information will be redundant.A 9.5f flexible ureteroscope and a sensor wire guide from other manufacturers were used during the flexible urs procedure on (b)(6) 2023.The laser was completed before the extractors were deployed, and the stones were then very small fragments only.The use of two ngage extractors was attempted during the same procedure for the same patient.The exactors were tested prior to use and were in an uncoiled position.They noted that a "clicking" sound could be heard as the first ngage was opened and closed before it was used in the procedure, and it was not a smooth opening/closing.The handle was in the straight position and towards the patient¿s body.No attempt was made to close the baskets prior to removal from the plastic tray.The baskets were not broken or separated.The first extractor was deployed and at first appeared to open and close for the procedure, however it then became impossible to open/close mid procedure and was removed.A new ngage was opened and tested, however part way through the procedure the extractor would not open/close.The device functioned "once or twice" prior to the failure.No tortuous patient anatomy issues were noted.As reported, the patient did not experience any adverse effects and the procedure was completed with another manufacturer's device.

Manufacturer Narrative

Event summary: it was reported that two baskets failed to open during a flexible ureteroscopy and stone ablation procedure.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.Investigation / evaluation: a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection and functional test of the device were conducted.Two devices were returned to cook for evaluation.The baskets would not open/close for either device.There was no damage to the baskets observed.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search identified two other complaints had been reported for this lot.The other complaints were likely related.Cook also reviewed product labeling.The product ifu did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for the issue had not yet been determined.The issue was identified as being with the basket assembly, which is a supplied component.A scar (supplier corrective action request) and capa (corrective and preventative action) were created to address the issue.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures have been initiated to address this failure mode.A capa is in progress to further investigate this failure mode with this device.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: 17572415
• MDR Text Key: 321530908
• Report Number: 1820334-2023-01105
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482965
• UDI-Public: (01)10827002482965(17)260111(10)15159846
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NGE-017115
• Device Lot Number: 15159846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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
• Treatment: 9.5F FLEXIBLE URETEROSCOPE (STORZ).; SENSOR WIREGUIDE (BOSTON SCIENTIFIC).