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

Catalog Number NTSE-022115-UDH

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: patient safety analyst.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a ncircle tipless stone extractor, a small distal portion of the basket broke off the instrument.It is not known how the device fragment was retrieved, or how the procedure was completed at this time.No adverse effects to the patient have been reported as a result of this occurrence.Additional details regarding the patient and event have been requested, at this time, no additional information has been provided.

Event Description

Additional information received 04aug2020: during a ureteroscopy, the basket broke within ureter.The broken piece was "free-floating" and not attached to retrieval wires.Multiple attempts were made to access the area to retrieve the broken piece.However, it was unable to be retrieved.This was determined to not be possible as the ureter was fibrotic and scarred.It is unknown if patient will require additional procedure to remove object in future but at this time nothing has been scheduled.The basket was tested prior to use.The reported stone size was a 6mm stone at mid/proximal right ureter per kub done prior to procedure.A stent was passed over a guidewire through the ureter and into the kidney (left renal pelvis as well as within the bladder) to complete the procedure.

Manufacturer Narrative

D11: concomitant products: 21fr olympus cystopscope, biopsy forceps, 0.035 guidewire, 7fr graduated olympus scope, 365 micron laser fiber, 2.7fr segura basket, 2.2fr basket.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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

On 10aug2020 a med watch report (mw5095702) was received.The issue described in previous reports, occurred, during cystoscopy with ureteroscopy with removal/manipulation of stones.A section of the device remains in the patient's ureter.

Manufacturer Narrative

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

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.Event summary: during a ureteroscopy, using a ncircle tipless stone extractor, a small distal portion of the basket broke off the instrument.The broken piece was "free-floating" and not attached to retrieval wires.Multiple attempts were made to access the area to retrieve the broken piece.However, it was unable to be retrieved.This was determined to not be possible as the ureter was fibrotic and scarred.It is unknown if patient will require additional procedure to remove object in future but at this time nothing has been scheduled.The basket was tested prior to use.The reported stone size was a 6mm stone at mid/proximal right ureter per kub done prior to procedure.A stent was passed over a guidewire through the ureter and into the kidney (left renal pelvis as well as within the bladder) to complete the procedure.No adverse effects to the patient have been reported as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.No physical examinations were able to be conducted.A document-based investigation evaluation was performed.No related non-conformances were found, and no other lot-related complaints have been received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which caution, ¿do not use excessive force to manipulate this device.Damage to the device may occur,¿ and, ¿this device is conductive.Avoid contact with any electrified instrument.¿ based on the information available, cook has concluded that possible causes for this event include excessive force applied to the device, breaking the wires attaching the basket to the remainder of the device; exposure of the wires to a laser during the procedure; and physical damage such as kinking that would weaken the wires.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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
• MDR Report Key: 10349744
• MDR Text Key: 201546334
• Report Number: 1820334-2020-01397
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)230102(10)10242147
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 10242147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 100