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

Catalog Number NGE-017115-MB

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/10/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer entity = (b)(6) e1: customer street = (b)(6) e1: customer line 2 = (b)(6) e1: customer phone = (b)(6) g4: pma/510(k) number = exempt h3: device evaluated by mfg = other (code unspecified, describe in h10) (81) - 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 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

As reported, the user inspected the ngage nitinol stone extractor before use, and it was discovered that the basket would not open.Another same device was used to complete the procedure.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.As reported, the user inspected the ngage nitinol stone extractor before use and it was discovered that the basket would not open.Another same device was used to complete the procedure.No adverse effects have been reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and function test of the returned device, were conducted during the investigation.Cook received one device in an open package with label.When the handle was actuated, the basket did not open/close.No damage to the device noted.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the reported lot and records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu, t_shef_rev1; the ifu did not provide any information related to the reported issue.The information provided upon review of the dmr, dhr, and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for the failure of the basket to open could not be 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: 18481180
• MDR Text Key: 332995211
• Report Number: 1820334-2024-00048
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482958
• UDI-Public: (01)10827002482958(17)260608(10)15480117
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 15480117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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