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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Customer name and address: phone: (b)(6).Initial reporter occupation: pharmacist.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

As reported, the junction of the two handles on an ncircle tipless stone extractor basket was completely loose when it was attempted to be used.They were not able to remove the stone with this device.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Event Description

Additional information received on 23mar2023: another device of the same type was used to complete the procedure.There were no adverse effects to the patient.

Manufacturer Narrative

) event summary: as reported, the junction of the two handles on an ncircle tipless stone extractor basket was completely loose when it was attempted to be used.They were not able to remove the stone with this device.Another device of the same type was used to complete the procedure.There were no adverse effects to the patient.Investigation ¿ evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures were conducted during the investigation.The device was not returned to cook for investigation.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.Because adequate inspection activities had been established it was concluded that there was no evidence that nonconforming product exists in house or in field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook concluded that the limited amount of provided information and lack of complaint device for investigation prevented a cause for the issue from being determined.Based on the provided event description, it was likely the issue with the device was that the basket sheath or support sheath separated near the handle.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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: 16418026
• MDR Text Key: 310333806
• Report Number: 1820334-2023-00167
• Device Sequence Number: 1
• Product Code: FFL
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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