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

Catalog Number NGE-017115

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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, 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, prior to use for an unknown procedure involving ureteroscopic lithotripsy, the user dismantled an ngage nitinol stone extractor's basket and found the basket would not open upon pushing the switch.The device did not make patient contact.Another same type device was used to complete the procedure.As reported, a patient did not require any additional procedures or experience any adverse effects 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.Investigation ¿ evaluation.As reported, prior to use for an unknown procedure involving ureteroscopic lithotripsy, the user dismantled an ngage nitinol stone extractor's basket and found the basket would not open upon pushing the switch.The device did not make patient contact.Another same type device was used to complete the procedure.As reported, a patient did not require any additional procedures or experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection of the returned device, were conducted during the investigation.One device was returned to cook for evaluation in an open package with label.Upon inspection, basket wires are cut, and the cut basket wires showed evidence of charring.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 identified two other complaints associated with the reported device lot.The information provided upon review of complaint file, device history record, complaint history and quality control documents do 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 are nonconforming.Cook also reviewed product labeling.The product ifu, t_shef_rev1 provides the following information: suggested handling instructions for extractors and forceps caution: this device is conductive.Avoid contact with any electrified instrument.Important: excessive force could damage device.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for the damage 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.

• 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: 18466135
• MDR Text Key: 332329180
• Report Number: 1820334-2024-00035
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260523(10)15457144
• 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
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 15457144
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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