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

Model Number N/A

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

As reported, during an unknown procedure, an ncircle tipless stone extractor's basket would not open and became kinked.The patient was not injured.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: urology coordinator 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.

Event Description

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

Manufacturer Narrative

Correction: d9, h3, h6 (annex g).Investigation ¿ evaluation.As reported, during an unknown procedure, an ncircle tipless stone extractor's basket would not open and became kinked.The patient was not injured.A section of the device did not remain inside the patient¿s body.The 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), drawing, instructions for use (ifu), manufacturing instructions (mi), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 did not identify any 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 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 _ ntse_ rev1; the ifu did not provide any information related to the reported issue.Based on the available information, no product returned, and the results of the investigation, the nature and cause of the issue could not be determined.There are multiple possible causes for the reported issue of the basket not opening and closing properly.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: NCIRCLE TIPLESS 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: 18739322
• MDR Text Key: 336771393
• Report Number: 1820334-2024-00239
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2024

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: NTSE-015115
• Device Lot Number: 15588503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 07/03/2024
• Supplement Dates FDA Received: 07/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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