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

Catalog Number NTSE-022115-UDH

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # - exempt.Device code: retraction problem is not labeled.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 the ncircle tipless stone extractor was used during a ureteroscopy with stone extraction procedure.The ncircle tipless stone extractor opened properly when it was removed from the packaging.When deployed in patient the basket would not retract back into the sheath.Basket had to be cut to be removed from the ureteroscope and patient.Therefore, a new basket was opened to complete the procedure.The kidney stones were removed and the procedure was completed successfully using the new basket.There were no adverse effects to the patient due to this reported occurrence.

Manufacturer Narrative

(b)(4).Investigation ¿ evaluation: the device was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A search of the north american distribution center database shows that all devices from lot 8681355 have been shipped.No similar product from the same lot is available for investigation.A document based investigation was performed.A review of complaint history, the device history record, instructions for use, manufacturing instructions and quality control data was conducted.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history revealed a second complaint associated with lot number 8681355.The second complaint was created for a different issue from the same customer.The instructions for use includes the following information in the precaution section: enclose the device in the sheath before removing from the tray/holder.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 complaint device was not returned.Possible causes for the basket to not to close during use includes the device being damaged from handling, a manufacturing issue, and operational context.Without the device, a definitive cause for the reported issue could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

No new event information has been received since the last report was submitted on 18july2018.

• 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: 7698362
• MDR Text Key: 114430636
• Report Number: 1820334-2018-02131
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)210321(10)8681355
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 8681355
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1