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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: exempt.Name and address: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a transurethral lithotripsy, the basket wire of a ncircle tipless stone extractor was damaged, and the basket became unusable.The device was tested prior to use, and it functioned properly at this time.The device was inserted through a flexible ureteroscope.The stone was located in the kidney.After opening and closing the basket a few times, the basket wire was damaged and elongated.Therefore, another same type device was used to complete the procedure.No section of the device remained inside of the patient's body.There have been no adverse effects to the patient reported.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Event summary: as reported, during a transurethral lithotripsy, the basket wire of a ncircle tipless stone extractor was damaged, and the basket became unusable.The device was tested prior to use, and it functioned properly at this time.The device was inserted through a flexible ureteroscope.The stone was located in the kidney.After opening and closing the basket a few times, the basket wire was damaged and elongated.Therefore, another same type device was used to complete the procedure.No section of the device remained inside of the patient's body.There have been no adverse effects to the patient 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.A device failure analysis was conducted on the returned device.The device was returned without the original packaging, but the original label was returned.The mlla (male luer lock adapter) was loose, but the collet knob was tight.The spacer was present.The purple support sheath and basket sheath were severed and had slid up the wire.The basket was unable to be used due to the damage.Therefore, the customer complaint was confirmed.In order to examine the basket formation, the basket sheath and support sheath were slid off the wire.The basket appeared fully intact.A review of the device history record (dhr) 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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.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 returned device was found to have a basket that was not functional due to sheath damage.The support sheath was separated near the handle.The cause for the damage was unknown.Excessive force may have been inadvertently applied to the device, however no information was known regarding device handling, therefore the cause of the issue could not be conclusively determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• 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 ; 8128294891
• MDR Report Key: 12526565
• MDR Text Key: 273138323
• Report Number: 1820334-2021-02214
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002462066
• UDI-Public: (01)10827002462066(17)240319(10)13834446
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 13834446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• 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
• Treatment: OLYMPUS P7 URETEROSCOPE; OLYMPUS P7 URETEROSCOPE
• Patient Sex: Male