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

Catalog Number NGE-017115

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: - customer (person) - (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.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

It was reported that during an unspecified procedure to "remove stones", the basket wires of an ngage nitinol stone extractor detached during the stone removal process.The procedure was successfully completed with another same type device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex g) investigation ¿ evaluation it was reported that during an unspecified procedure to "remove stones", the basket wires of an ngage nitinol stone extractor detached during the stone removal process.The procedure was successfully completed with another same type device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including 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 ngage nitinol stone extractor was returned in an open package with label to cook for evaluation.Upon inspection, the basket formation had wires pulled free from the shrink tube and basket sheath.The shrink tube and glue that secured the basket to the basket sheath did not hold the two components together.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 one possible recorded non-conformances relevant to the failure mode.A database search identified three other complaints associated with the reported device lot.Two of the three recorded complaints are for the same failure mode as this complaint.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, t_shef_rev1, 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 this event could not be determined.The basket assembly is manufactured by a supplier.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.

• 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: 18354546
• MDR Text Key: 330879025
• Report Number: 1820334-2023-01728
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260612(10)15484295
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115
• Device Lot Number: 15484295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• 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