MAUDE Adverse Event Report: COOK INC NCIRCLE 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 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - additional customer data: postal code = (b)(6) // 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, 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 transurethral lithotripsy, a ncircle tipless stone extractor's basket failed to open or close.The device was tested prior to use in an uncoiled state and was discovered at that time to not function properly; so it's use was discontinued.Another manufacturer's scope was being used.No laser was used in proximity of the basket.Patient anatomical issues were denied.To see if the device could be fixed, the user removed the black screw at the rear end of the handle and disassembled it."the core inside fell out and he could not get it back." the procedure was completed by using another ncircle tipless stone extractor (lot# unknown) from the hospital inventory.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported that an ncircle tipless stone extractor's basket failed to open or close prior to a transurethral lithotripsy.The device was tested prior to use in an uncoiled state and was discovered at that time to not function properly; so it's use was discontinued.Another manufacturer's scope was being used.No laser was used in proximity of the basket.Patient anatomical issues were denied.To see if the device could be fixed, the user removed the black screw at the rear end of the handle and disassembled it."the core inside fell out and he could not get it back." the procedure was completed by using another ncircle tipless stone extractor (lot# unknown) from the hospital inventory.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), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.Cook received one device for evaluation.The returned device was found to have the cannulated handle protruding from the distal end of the handle.The cannulated handle was bent.This was due to the user disassembling the device and not being able to properly reassemble the components.The altered condition of the device prevented the cause for the failure to open/close from being established.The basket could not be functioned.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the reported lot and records no relevant non-conformances related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu, t _ ntse_ rev1, provides the following information to the user: precaution: the device is conductive.Avoid contact with any electrified instrument.Precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The information provided upon review of the dmr, dhr, and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, the altered condition of the returned device, and the results of the investigation, a cause was unable to be established.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: 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: 18486857
• MDR Text Key: 332912515
• Report Number: 1820334-2024-00054
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)261016(10)15709568
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 15709568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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