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

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported the basket of an 'ncircle tipless stone extractor' separated during a transurethral lithotomy (tul) procedure in a male patient.The device was inspected and tested prior to use and functioned as intended.During the first stone extraction, the extractor was deployed through a rigid ureteroscope under fluoroscopy directly above the stone, an attempt was made to capture and extract the stone.The basket became stuck while grasping the stone, and the stone would not release.While attempting to open and close the basket and move the entire device in an attempt to dislodge the stone, the basket portion detached and remained in the renal pelvis of the patient, with the stone in its grasp.The captured stone was crushed with a competitor device, and the basket was removed from the patient's body using forceps.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

E1: customer (person) phone: (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.

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, unavailable, or unchanged.Corrections: h6 (annex a, annex g) investigation evaluation it was reported the basket of an 'ncircle tipless stone extractor' separated during a transurethral lithotomy (tul) procedure in a male patient.The device was inspected and tested prior to use and functioned as intended.During the first stone extraction, the extractor was deployed through a rigid ureteroscope under fluoroscopy directly above the stone, an attempt was made to capture and extract the stone.The basket became stuck while grasping the stone, and the stone would not release.While attempting to open and close the basket and move the entire device in an attempt to dislodge the stone, the basket portion detached and remained in the renal pelvis of the patient, with the stone in its grasp.The captured stone was crushed with a competitor device, and the basket was removed from the patient's body using forceps.As reported, the patient did not experience any adverse effects or require any additional procedures 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 were conducted during the investigation.Visual inspection of the returned complaint device was also conducted.One, used, 'ncircle tipless stone extractor' was returned for investigation.The basket formation was not initially returned; no damage was noted to the returned section.The separated basket was returned at a later date and was found to be damaged and deformed.The two wires of the basket assembly that connect the basket to the handle were broken just proximal of the basket cannula that forms the proximal end of the basket; the broken ends of the wires showed signs that the wires broke under tension; the basket wires were also noted to be deformed.Cook has concluded that the device was manufactured to specification.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 related non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device for lot.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there was no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling; the ifu [t _ ntse_ rev1] supplied with the device states the following in consideration of the reported failure mode: - 'precaution: do not use excessive force to manipulate this device.Damage to the device may occur.' the returned device was found to have a separated basket as reported.The two wires of the basket assembly that connect the basket to the handle were broken just proximal of the basket cannula that forms the proximal end of the basket.The broken ends of the wires showed signs that the wires broke under tension.There was no damage to the remainder of the device.Based on the information provided by the user, the stone became stuck inside the basket and all the observed damage was caused by attempts to remove the stone from the basket.The returned device did not have any damage other that with the separated basket.The size of the stone was not known, but it was possible the size of the stone made it difficult to remove the stone from the basket inside the renal pelvis.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.

• 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: 18260876
• MDR Text Key: 329683619
• Report Number: 1820334-2023-01617
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)260825(10)15628431
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: NTSE-022115-UDH
• Device Lot Number: 15628431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2023
• 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
• Treatment: RIGID URETEROSCOPE.
• Patient Sex: Male