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

Model Number	G17940
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: technical/regulatory affairs manager.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 prior to a ureterolithotripsy, a nforce nitinol helical stone extractor was tested and found to not open and close.Another unknown extractor was opened to finish the procedure.No adverse effects to the patient were reported due to this occurrence.
Event or Problem Description
No new patient or event information since the last report was submitted.
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 was returned for investigation.Inspection of the returned device noted the device was returned with the handle and the basket formation in the open positions.The mlla (male lur lock adapter) and collet knob were tight.The polyethylene terephthalate tubing [pett] measured 1.6 cm in length.There were no kinks in the basket sheath.The basket sheath and the support sheath were still attached.With the udh handle in the open position, the distal cannula and coil protrudes in the basket sheath by 2 cm.The basket wires appeared discolored.Functional testing noted the handle does not actuate the basket formation.The handle was then disassembled.Further visual exam noted the coil assembly was stretched and prevented the device from functioning.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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 lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.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 stretch basket coil (the component that connects the basket to the handle) that was preventing the basket from functioning properly.The cause for the damaged basket coil could not be determined.The provided information stated the issue occurred before use.It is possible the device was damaged during unpacking or subsequent handling, or the device was damaged during packaging.There is not enough evidence available to determine a likely cause for the failure of the basket to close.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.

• Brand Name: NFORCE NITINOL HELICAL 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: 9438345
• Report Number: 1820334-2019-03046
• Device Sequence Number: 14503674
• Product Code: FFL
• UDI-Device Identifier: 00827002179400
• UDI-Public: (01)00827002179400(17)210625(10)NS8974859
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 06/25/2021
• Device Model Number: G17940
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: NS8974859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR