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

Catalog Number NTSE-015115

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported, that during a ureteroscopy a cook nitinol basket was used for stone retrieval.When the basket was tightened around the stone the shaft's end split and opened up so that when it was re-introduced into the scope, the scope broke.Clarification of this event, concomitant devices, and size of scope utilized in the case has been requested.The customer has stated the device will be returned for evaluation.No patient harm was reported.

Event Description

Additional information received on 10january2019.Several stones, size from 2 mm to 3mm were being removed from the patient.There was no difficulty.The procedure went well.After the procedure, the patient was stone free and spent one night in the urological ward.

Manufacturer Narrative

Investigation evaluation.The complaint device was not returned for an evaluation.No photographs or imaging was provided for review.A search of the north american distribution center (nadc) database shows that all devices from lot number 9238996 have been shipped.No similar product from the same lot is available for investigation.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data, and trends.A review of the device history record for lot # 9238996 found there were no non-conformances that would have caused or contributed to the reported failure.A review of complaint history records revealed no other complaints have been associated with the complaint device lot number 9238996.The instructions for use (ifu) states the following in consideration of 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 complaint device was not returned.A device was returned for another complaint with the same issue reported at the same time as this complaint.Evaluation of that device found the distal end of the sheath was damaged.There was a kink 1mm from the tip, and the tip had a flared appearance.This does match the event information that the end of the device was deformed from grasping stones.It appears likely too much force was applied in capturing the stones, damaging the end of the sheath.The ifu contains cautions about using excessive force when manipulating the device.Based upon the evaluation of the returned device from the same facility and for the same failure mode, it was concluded the device was inadvertently damaged when capturing the stones.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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.

Event Description

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

• 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: 8203103
• MDR Text Key: 132055635
• Report Number: 1820334-2018-03868
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)211016(10)9238996
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: NTSE-015115
• Device Lot Number: 9238996
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS URFV3
• Patient Age: 54 YR
• Patient Weight: 96