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

Model Number N/A

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/26/2023

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.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, during a transurethral endoscopy (tul), a urinary stone in the renal pelvis and ureter was scheduled to be crushed and retrieved.During the first attempt to retrieve a stone in the inferior renal calyx, an ncircle delta wire tipless stone extractor's basket failed to deploy.The device performed well when checked in an uncoiled position, for its function prior to use.During its use, the device worked well in a straight position, but could not be operated when it was bent (the endoscope was angled).Per the reporter, the patient's anatomy did not contribute to the malfunction of the device.A laser was not used with the complaint device.Another same type device was used to complete the procedure.A section of the device did not remain in the patient.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.

Manufacturer Narrative

Event summary as reported, during a transurethral endoscopy (tul), a urinary stone in the renal pelvis and ureter was scheduled to be crushed and retrieved.During the first attempt to retrieve a stone in the inferior renal calyx, an ncircle delta wire tipless stone extractor's basket failed to deploy.The device performed well when checked in an uncoiled position, for its function prior to use.During its use, the device worked well in a straight position, but could not be operated when it was bent (the endoscope was angled).Per the reporter, the patient's anatomy did not contribute to the malfunction of the device.A laser was not used with the complaint device.Another same type device was used to complete the procedure.A section of the device did not remain in the patient.The patient did not require any other additional intervention or experience any adverse effects due to this occurrence.Investigation ¿ evaluation 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 (qc) procedures.A visual inspection and functional test of the device were conducted during the investigation.One device was returned in open packaging with the label.When the handle was actuated, the basket opened/closed as intended.There was no damage to the device noted.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records found no other complaints reported for the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.A review of relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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, cook has concluded a cause for the issue could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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: NCIRCLE DELTA WIRE 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: 18574045
• MDR Text Key: 333822033
• Report Number: 1820334-2024-00115
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002191102
• UDI-Public: (01)10827002191102(17)260814(10)15608202
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: NTSED-024115-UDH
• Device Lot Number: 15608202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• 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