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

Model Number G46206

Device Problems Loss of or Failure to Bond (1068); Device Damaged Prior to Use (2284); Difficult to Open or Close (2921)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = 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 a transurethral lithotomy (tul) procedure to retrieve a stone located in the upper urinary duct, the ncircle tipless stone extractor was damaged and unable to close.The device was inspected and tested prior to use and did not work properly.No part of the device was separated.Another same-like device was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: d4.H6 - medical device problem code (annex a), component code (annex g).Investigation evaluation description of event: as reported, prior to a transurethral lithotomy (tul) procedure to retrieve a stone located in the upper urinary duct, the ncircle tipless stone extractor was damaged and unable to close.The device was inspected and tested prior to use and did not work properly.No part of the device was separated.Another same-like device was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures, as well as interview personnel, a visual inspection, and functional test of the returned device, were conducted during the investigation.One returned ncircle tipless stone extractor in an open package with label.Basket was not visible.Basket wire was visible - protruding from support sheath.Handle would actuate basket wire - sheath would move with wire.Basket wire had been pulled into the sheath; handle had been reassembled possibly by customer as the collett knob was over tightened.Basket wire was pulled from sheath to examine basket which was intact and undamaged.Additionally, 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 record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in the field.The ifu does not provide any information related to the reported issue.The returned device was found to have a basket that was closed and could not be opened due to separation of the basket sheath from the purple support sheath.The cause for the separation could not be established.Cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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: 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: 19075477
• MDR Text Key: 339992373
• Report Number: 1820334-2024-00491
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)261102(10)15738848
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2024

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: G46206
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 15738848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 09/12/2024
• Supplement Dates FDA Received: 09/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• 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