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

Catalog Number NTSE-030115-UDH

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

Occupation = non-healthcare professional - regulatory affairs program coordinator.Pma/510(k) number = exempt.Device evaluated by mfg = other - unknown if device will be returned after removal.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a ncircle tipless stone extractor basket broke around the stone during use and was retained in the patient.The stent was placed in the right ureter as intended.Another ncircle tipless stone extractor was used to attempt to remove the retained piece but was unsuccessful.The patient is scheduled for a pcnl for stone removal prior to discharge and the provider will attempt to locate and remove the remaining portion of the complaint device during that time.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

Summary of event: it was reported that a ncircle tipless stone extractor basket broke around the stone during use and was retained in the patient.The stent was placed in the right ureter as intended.Another ncircle tipless stone extractor was used to attempt to remove the retained piece but was unsuccessful.The patient is scheduled for a pcnl for stone removal prior to discharge and the provider will attempt to locate and remove the remaining portion of the complaint device during that time.Corrected information: e4, h6 (annex g).Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were 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 information provided upon review of complaint file, device history record, complaint history, and quality control documents provides evidence to support that the device was manufactured to specification.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: 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.A possible cause for the basket separating from the device is that excessive force may have been inadvertently applied to the device during use, resulting in breakage of the basket assembly.The instructions for use (ifu) contains a precaution to not use excessive force to manipulate the device because damage to the device may occur.However, based on the limited information available, cook has concluded that a definitive cause of the reported event 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.

Event Description

Additional information received 04aug2022 via medwatch.The patient was undergoing a right ureteroscopy and lithotripsy due to an impacted stone using another manufacturer's laser device.5% of the basket was left around the stone.The complainant reported that the basket broke "likely due to too much traction" but not due to "contact/interference with laser or faulty basket".Patient was stable upon exiting the operating room and arrival to pacu (post-anesthesia care unit).

Manufacturer Narrative

Medwatch #: (b)(4) was received 04aug2022.Mdr number 1820334-2022-01344 captured the event from the medwatch, however, the investigation of 1820334-2022-01344 indicated that the medwatch was the same event as mdr number 1820334-2022-00435 (subject of this complaint).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: 13862579
• MDR Text Key: 287700909
• Report Number: 1820334-2022-00435
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002176277
• UDI-Public: (01)10827002176277(17)241220(10)14430975
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-030115-UDH
• Device Lot Number: 14430975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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
• Treatment: FORTEC MEDICAL LASER DEVICE.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female