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

Catalog Number NTSE-022115-UDH

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported that during a ureteroscopy with stone extraction, an ncircle tipless stone extractor was in use, but found not to close completely.Then when attempting to withdraw the device from the endoscope the tip broke off.The bladder was then flushed to remove the separated portion.Another same device was opened to complete the procedure.It was reported that no portion of the device were left within the patient and the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: it was reported on (b)(6) 2020 of an incident involving a ncircle tipless stone extractor.The device reportedly had a basket tip that separated during removal from the endoscope during a ureteroscopy with stone extraction procedure on (b)(6) 2020.Further communication with the user facility clarified that ¿while retrieving the stone, the basket was not closed entirely, and the basket tip broke off during withdraw from the endoscope.The bladder was flushed to remove the separated portion.The procedure was completed with another of the same device.¿.The patient reportedly experienced no additional harm as a result of the issue.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, drawings, the instructions for use, manufacturing instructions, and quality control data.One ncircle tipless stone extractor was returned for investigation.Visual inspection of the returned device noted the device was returned with the handle in the open position and the basket formation in the closed position.The mlla (male luer lock adapter) was loose, and the collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured approximately 2.5 cm.The basket sheath was severed 43cm from the distal tip and again at 43.6cm from the distal tip.There was 2cm of the coil exposed, and the coil was partially severed.Functional testing determined the handle does not actuate the basket formation.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.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 closed and could not be opened due to sheath damage.The basket sheath was separated 43 cm from the distal end.The separated sheath prevented the motion of the handle from opening the basket.The basket coil under the basket sheath was damaged in the same location.It appears the sheath was damaged during use, likely when inserting the sheath into the scope.There is no information provided related to device handling during use, therefore the cause for the sheath damage 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.

Event Description

No new patient or event information 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: 9888167
• MDR Text Key: 197143244
• Report Number: 1820334-2020-00700
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002187785
• UDI-Public: (01)10827002187785(17)221226(10)10232796
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2022
• Device Catalogue Number: NTSE-022115-UDH
• Device Lot Number: 10232796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WOLF DUAL OPERATING CHANNEL SCOPE