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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

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

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510k # ¿ exempt.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unspecified procedure, the basket of an ncircle tipless stone extractor broke off in the ureter.There was a "big" stone in the basket and while they were bringing it down the ureter to remove it, it got stuck in the ureter.The user was pulling "pretty hard" when the basket broke off in the ureter.A laser was used to crush the stone into smaller pieces.Another ncircle extractor was used to grab the stone fragments and they were able to sweep the basket head out of the ureter, into the bladder, and remove the basket head from the patient with alligator graspers.No portion of the device was left in the patient.The patient did not require any additional procedures due to this occurrence.No additional patient consequences were reported.

Manufacturer Narrative

Description of event: as reported, during an unspecified procedure, the basket of an ncircle tipless stone extractor broke off in the ureter.There was a "big" stone in the basket and while they were bringing it down the ureter to remove it, it got stuck in the ureter.The user was pulling "pretty hard" when the basket broke off in the ureter.A laser was used to crush the stone into smaller pieces.Another ncircle extractor was used to grab the stone fragments and they were able to sweep the basket head out of the ureter, into the bladder, and remove the basket head from the patient with alligator graspers.No portion of the device was left in the patient.The patient did not require any additional procedures due to this occurrence.No additional patient consequences were reported.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned in its shipping tray inside an open outer package.The handle was returned in the open position.The basket formation was severed and inside well of the shipping tray.Two wires extended from the distal cannula measuring approximately 3 mm.The basket wires were noted to be asymmetrical.Kinks were noted in the basket sheath 22 cm and 81 cm from the distal tip.The collet knob and male luer lock adapter (mlla) were tight.The basket and support sheaths were still adhered.The cannulated handle was not caught in the collet.The handle was disassembled and the coil assembly could be manually actuated.The handle was reassembled-assuring cannulated handle was caught in the collet.The handle would actuate the coil assembly.A review of the device history record found no non-conformances related to the reported failure mode.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 there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The two wires that connect the basket assembly to the handle were broken 3 mm from the basket cannula.The provided information stated that a large amount of force was applied to the device while attempting to remove a large stone from the ureter.Based on the analysis of the returned device and information provided by the user, it was determined the basket separated due to excessive force being applied to the device during use.The ifu contains a caution that excessive force may cause damage.Other damage to the device was noted, with the damage likely occurring after separation of the basket.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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

There is no new patient or event information to report.

• 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: 12832285
• MDR Text Key: 281013187
• Report Number: 1820334-2021-02509
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)240719(10)14095974
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 14095974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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
• Patient Outcome(s): Required Intervention