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

Catalog Number NTSE-015115

Device Problem Break (1069)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

As reported, during a urinary stone extraction procedure, a basket wire from an ncircle tipless stone extractor broke after extracting one or two stones (subject of this report).The procedure was continued with another basket (see patient identifier (b)(6)), but the basket wire also broke after removing one to two stones.Both devices were tested prior to use in an uncoiled position and functioned properly.A laser was not used concomitantly with either device.No parts of either device fully separated.No device segment was left in the patient.Another basket was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(6).Pma/510(k) number = 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event description: as reported, during a urinary stone extraction procedure, a basket wire from an ncircle tipless stone extractor broke after extracting one or two stones (subject of this report).The procedure was continued with another basket (see manufacturer report # 1820334-2022-01632), but the basket wire also broke after removing one to two stones.Both devices were tested prior to use in an uncoiled position and functioned properly.A laser was not used concomitantly with either device.No parts of either device fully separated.No device segment was left in the patient.Another basket was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One device was returned for investigation in open packaging in a packaging tray.The basket assembly was inspected and had a broken wire.Approximately 1mm of broken wire was protruding from the tip of the assembly with the remaining wire missing.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 dhr for this lot records no relevant non-conformances.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 current instructions for use cautions, "the device is conductive.Avoid contact with any electrified instrument," and, "do not use excessive force to manipulate this device.Damage to the device may occur." the information provided upon review of product labeling review, device master record and device history record, confirmed the device was manufactured to specification and the items.Cook confirmed the returned device was found to have 1 of the 4 basket wires broken.The wire was broken near the tip of the basket, with the broken wire missing.The second complaint that occurred during the same procedure was found to have the same failure mode.Two devices experiencing the same issue indicates a possible procedural related issue that affected both devices.No information related to any possible procedural related issues was provided.Therefore, cook has concluded the cause for this issue could not be determined.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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: 15594768
• MDR Text Key: 306984497
• Report Number: 1820334-2022-01631
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)250720(10)14849951
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 14849951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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