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

Catalog Number	NTSE-022115-UDH-MB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # - exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, the surgeon may have pulled a little too hard but the ncircle tipless stone extractor basket broke today when he was pulling a 1.2cm kidney stone out during a percutaneous nephrolithotomy pcnl procedure.Half of the basket part (nitinol wire) did separate but it was retrieved by a flexible grasper.All pieces (2) are believed to have come out.They were using a karl storz flexible nephroscope with a 7fr inner diameter.As reported, no unintended section of the device remained inside the patient¿s body.There were no additional procedures required and there were adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
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.One device returned to manufacturer for investigation.Returned product label confirms lot number 9206144.The device was returned with the handle and the basket formation in the open position.The male luer lock adapter (mlla) is finger tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 1.5 cm in length.Functional testing determined the handle actuates the basket formation.Visual examination noted the basket formation was returned with 2 wires separated from the coil assembly.The 2 wires are broken at the knot.There are kinks in the basket sheath located at 48 cm, 49 cm, and 110 cm from the distal tip.A review of the device history record for lot 9206144 found there were no non-conformances.A review of complaint history records shows no other complaints associated with the complaint device lot number 9206144.The instructions for use (ifu) contains the following precautions: 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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The returned device was found to have a separated basket.The basket cannula and two basket wires had separated from the remainder of the device.No part of the returned device was missing.The provided information stated that the user may have inadvertently applied excessive force to the device, causing the basket to separate.The investigation conclusion is cause traced to user; unintended use error caused or contributed to the event.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 or Problem Description
No new event information has been received.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8285249
• Report Number: 1820334-2019-00288
• Device Sequence Number: 11124976
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)211002(10)9206144
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: NTSE-022115-UDH-MB
• Device Lot Number: 9206144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KARL STORZ FLEXIBLE NEPHROSCOPE; KARL STORZ FLEXIBLE NEPHROSCOPE
• Patient Age: 62 YR