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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that the distal end of a ngage nitinol stone extractor basket detached and could not be opened during a stone removal procedure.A customer provided photo shows a basket wire detached from the basket sleeve.The device was not tested prior to use, and was unable to retrieve any stones.No adverse effects have been reported for this incident.A related complaint from the same customer for a different patient is reported under patient identifier #(b)(6).Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

E1- customer (person) information: (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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: b5, h6 health effect - clinical code annex e, health effect - impact code annex f additional information: d9, h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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

Information was available but inadvertently omitted from the previous medwatch report.The procedure was successfully completed by the user changing to another same device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that the distal end of a ngage nitinol stone extractor basket detached and could not be opened during a stone removal procedure.A customer provided photo shows a basket wire detached from the basket sleeve.The device was not tested prior to use and was unable to retrieve any stones.No adverse effects have been reported for this incident.The procedure was successfully completed by the user changing to another same device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection of the device were conducted.One ngage nitinol stone extractor was returned to cook for evaluation in an open package with label.Upon inspection, wires of basket formation were pulled free from support sheath.The shrink tube and glue that secures the basket to the basket sheath had not held 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 no recorded non-conformances relevant to the failure mode.A database search identified one other complaint associated with the reported device lot for the same failure.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; the ifu 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 had not been determined.The basket assembly is manufactured by a supplier and a non-conformance investigation was created to investigate the issue.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: 18129408
• MDR Text Key: 328381277
• Report Number: 1820334-2023-01557
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260612(10)15484294
• 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,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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-017115
• Device Lot Number: 15484294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2024
• 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