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

Model Number N/A

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 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

E1- customer (person): line 2: (b)(6) // phone:(b)(6).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.

Event Description

It was reported that the distal tip of the basket of an ngage nitinol stone extractor was detached affecting the basket's advancement and retraction; it remained opened and would not close.In the customer provided photo, the detachment can not be seen, but the basket is seen in the open position.Because the basket could not be used, it was replaced with another same device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex a and annex g).Event summary: it was reported that the distal tip of the basket of an ngage nitinol stone extractor was detached affecting the basket's advancement and retraction; it remained opened and would not close.In the customer provided photo, the detachment can not be seen, but the basket is seen in the open position.Because the basket could not be used, it was replaced with another same device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation : reviews of the 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 returned device, were conducted during the investigation.One device was returned to cook for evaluation in an opened package with label.Upon inspection, the handle was actuated, and the basket did not open/close.The handle was taken apart and re-assembled with no change in function.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 did not identify any other complaints associated with the reported device lot.Review of the device history record, complaint history, quality control documents, and device failure analysis does not indicate that the device was manufactured out of specification and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_shef_rev1; the 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, a cause for the issue was not established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: 17627199
• MDR Text Key: 322322838
• Report Number: 1820334-2023-01158
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260404(10)15368958
• 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

• 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: 15368958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 12/07/2023
• 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