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

Catalog Number	NC3-024115
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510k # 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 that while setting up for an unspecified procedure using a ncompass nitinol stone extractor, one of the wires of the basket was found to be broken upon opening of the basket onto the sterile field.This device was never used on the patient.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Event or Problem Description
No new information has been provided due to privacy restrictions of the facility.
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, the device history record, drawings, the instructions for use, quality control data, and specifications.One device returned to manufacturer for investigation.Returned packaging confirms lot number 8991690.The complaint device was returned with the handle and the basket formation in the closed position.The male luer lock adapter (mlla) is loose.The collet knob is tight and secure.Polyethylene terephthalate tubing (pett) measures 1.5 cm in length.Functional testing determined the handle actuates the basket formation to the fully opened and closed positions.Visual examination noted kinks in the basket sheath, possibly from shipment to the manufacturer.Kink located 36 cm from the distal tip of basket sheath.Kinks located at 9.5 cm and 10.5 cm from the distal end of the support sheath.Two wires in the basket formation are broken; wires have the appearance of pulling out of weld.A review of the device history record found there were no non-conformances that would have caused or contributed to the reported failure mode.Additionally, the incoming inspections for the subassembly lots were reviewed.No defects were found from either lot during incoming qc inspections.Because there are no related non-conformances, adequate inspection activities have been established.There is objective evidence that the dhr was fully executed.A review of complaint history records shows that other complaints have been received on the complaint device lot # 8991690.The instructions for use (ifu) contains information related to the reported failure mode: caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.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 found to have a basket with two wires that appeared to have pulled from the distal basket cannula.Devices are inspected for damage and functionality prior to packaging.It was reported the issue was discovered prior to use of the device.The cause for the issue could not be determined.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.

• Brand Name: NCOMPASS NITINOL 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: 8173188
• Report Number: 1820334-2018-03782
• Device Sequence Number: 1747425
• Product Code: FFL
• UDI-Device Identifier: 00827002327023
• UDI-Public: (01)00827002327023(17)210702(10)8991690
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 07/02/2021
• Device Catalogue Number: NC3-024115
• Device Lot Number: 8991690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1