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 02/20/2023

Event Type  malfunction  

Event Description

As reported, two ngage nitinol stone extractors were not opening properly.Reference this report for device associated with lot number 15179862.Reference patient identifier (b)(6) for device associated with lot number 15120088.There were no adverse effects to the patient reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Pma/510k #: 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.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

Additional information was received 10mar2023: the procedure being performed was a normal kidney stone removal.The device was tested prior to use in an uncoiled position and there was no attempt to close the basket prior to removal from the plastic tray.The handle was in a straight position pointed towards the patient's body.A section of the device did not remain 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

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

Event summary: as reported, two ngage nitinol stone extractors were not opening properly.The procedure being performed was a normal kidney stone removal.Reference this report for device associated with lot number 15179862.Reference patient identifier (b)(6) for device associated with lot number 15120088.The device was tested prior to use in an uncoiled position and there was no attempt to close the basket prior to removal from the plastic tray.The handle was in a straight position pointed towards the patient's body.Both devices were in patient contact and they were able to complete the procedure with the second device which opened only partly.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: a functional test and visual inspection of the returned device were conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, instructions for use (ifu), and quality control procedures.Two devices were returned to cook in the same ziploc bag for investigation.It was not possible to determine which device was from which complaint.Device 1: support sheath has slight curve.Handle does not actuate basket assembly.Handle was disassembled.Handle was reassembled and could then actuate basket formation.A document-based investigation evaluation was performed.No related non-conformances were recorded.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The product ifu did not provide any information related to the reported issue.Based on the available information, cook concluded the cause for the issue could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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

Additional information received 04apr2023: both devices were in patient contact and they were able to complete the procedure with the second device which opened only partly.

• 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: 16504717
• MDR Text Key: 311479147
• Report Number: 1820334-2023-00235
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)260119(10)15179862
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• 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-022115
• Device Lot Number: 15179862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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