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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1- (b)(6).G4: pma/510k # ¿ exempt.H3: 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.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

As reported, it was discovered when the package of an ngage nitinol stone extractor was opened for a ureteroscopy procedure that the distal end of a basket wire was detached.The issue with this device was discovered prior to patient contact and it was not used on a patient.Another same device was used to complete the procedure.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.

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, unchanged, or unavailable.Event description: as reported, it was discovered when the package of an ngage nitinol stone extractor was opened for a ureteroscopy procedure that the distal end of a basket wire was detached.The issue with this device was discovered prior to patient contact and it was not used on a patient.Another same device was used to complete the procedure.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.Investigation ¿ evaluation a visual inspection and functional testing 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.One ngage nitinol stone extractor was returned in an opened labeled package and shipping tray.Upon inspection, the basket was separated from the basket sheath.The handle was actuated and the basket did not open/close.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 device history shows one non-conformance recorded for the shrink tube damaged.It is possible that it was a related issue to the complaint issue.The non-conformance report did not contain enough detail to conclusively determine if the issues are related.The device was scrapped.A review of complaint history records shows five other similar complaints associated with the complaint device lot.Adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.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 are nonconforming.The instructions for use (ifu) does not provide any information related to the reported issue.The returned device was found to have a basket that would not open due to separation of the basket from the basket sheath.The shrink tube and glue that secures the basket to the basket sheath had not held the two components together.The cause of the complaint could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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.

• 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: 17803316
• MDR Text Key: 324121408
• Report Number: 1820334-2023-01276
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: 15446255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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