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

Model Number	G46027
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was initially reported the devices broke/bent at the orange jacket that connects the basket wire to the handle during use.This has caused the device to fail and the basket to no longer open.Additional information was provided on 18-feb-2019.This is one complaint for a quantity of four (4) ncompass nitinol tipless stone extractors from lot #9342377.During the ureteroscopy w/laser lithotripsy procedure while using a flexible ureteroscope and a working sheath approximately 3.6 french, the orange tubing sheath that is beyond the handle broke/disconnected in all instances.The device was tested prior to use.There were no issues with patient anatomy that kept the basket from opening/closing.The doctor used a 2.2 ncircle basket to finish grabbing the stone fragments.Further clarification was received on 20-feb-2019.No unintended part of the device was left inside the patient¿s body.No additional procedures were required.There were no adverse effects to the patient as a result of this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A visual inspection and functional testing of the returned devices 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, quality control data, and specifications.Four empty pouches and three devices were returned for investigation.The returned packaging confirms lot number 9342377.Device a the device was returned with the handle between the open and closed positions.The basket formation is in the closed position.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.Visual examination noted the support sheath is severed at the nose of the mlla.There is a 1.2 cm gap between the points of separation exposing the cannulated handle.The distal segment of the support sheath and basket sheath are still adhered to the basket sheath.Functional testing notes the handle does not actuate the basket formation.Device b the device was returned with the handle in the open position and the basket formation is in the closed position.The male luer lock adapter (mlla) is loose.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.Visual examination noted the support sheath is severed at the nose of the mlla.With the handle in the opened position, 2.6 cm of the basket sheath is exposed.The distal segment of the support sheath and basket sheath are still adhered to the basket sheath.The basket assembly is bent at the end of the cannulated handle.Functional testing notes the handle does not actuate the basket formation.Device c the device was returned with the handle in the open position and the basket formation is in the closed position.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.Visual examination noted the support sheath is severed 2 mm from the nose of the mlla.There is a 4cm gap between the points of separation.The basket sheath is severed 2 mm from the nose of the mlla.There is a kink at 49 cm from the distal tip of the basket sheath.Functional testing notes the handle does not actuate the basket formation.A review of the device history record for lot 9342377 found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with complaint device lot 9342377.To conclude, three devices were returned.A visual exam notes the support sheath was severed on all returned devices.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 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.Three of the four complaint devices were returned for evaluation.All three returned devices were found to be non-functional due to the orange support sheath having separated near the handle.The devices were also found to have bent / kinked coil assemblies that resulted from the separated support sheaths.Basket devices are inspected for functionality and damage multiple times during manufacturing and quality control checks.The devices are also packaged with the baskets open, the baskets for all three complaint devices were found to be closed.The devices likely functioned normally when packaged, but became damaged during use.The cause for the damage could not be determined, but contributing factors may have been user technique, device orientation, patient anatomy, and / or stone location.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
There has been no new event information received since the last report was submitted.

• Brand Name: NCOMPASS NITINOL 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: 8355433
• Report Number: 1820334-2019-00483
• Device Sequence Number: 2197992
• Product Code: FFL
• UDI-Device Identifier: 00827002460270
• UDI-Public: (01)00827002460270(17)211129(10)9342377
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: 11/29/2021
• Device Model Number: G46027
• Device Catalogue Number: NCT4-017115
• Device Lot Number: 9342377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1