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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

As reported, during a lithotripsy procedure for stone removal, two ncircle tipless stone extractors (captured under mdr numbers - 1820334-2023-01541 and 1820334-2023-01720) and one ngage nitinol stone extractor (subject of this complaint) did not function properly and were unable to capture any stones.The first basket (mdr number: 1820334-2023-01541) would not close after it was opened.The basket was "flexible" and was able to be retracted and removed from the patient.The second basket (mdr number: 1820334-2023-01720) was used and would not open on the first attempt.A third basket was used (subject of this complaint) and would not open after multiple attempts.It was said that the user routinely tests the devices prior to use, though it is not known if they were in this instance.A laser was used during the procedure.The patient's anatomy was not tortuous, calcified, or scarred.The procedure was completed with a 4th same type device.A section of the device did not remain inside the patient's body.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 or unavailable.G4 - pma/510(k)#: exempt h3 - device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 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.

• 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: 18706486
• MDR Text Key: 336299073
• Report Number: 1820334-2024-00219
• Device Sequence Number: 1
• Product Code: FFL
• 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
• Report Date: 02/14/2024

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: 15422411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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