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

Catalog Number	NFHSES-032115-3W-UDH
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an nforce nitinol helical stone extractor was used during a nephrolithotripsy procedure.As reported, the basket opened and closed once, then it didn't open anymore.A new nforce nitinol helical stone extractor was opened and used to complete the procedure.There was no impact or adverse consequence to the patient due to this occurrence.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: conclusion code: cause not established (4315).Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The device was returned with the handle in the open position and the basket formation is closed.The collet knob is tight and secure.The male luer lock adapter (mlla) is tight.A visual examination noted the basket sheath and the support sheath are detached.A functional test determined the handle does not actuate the basket formation.The basket sheath appears to be severed 5.4 cm from the distal edge of the support sheath when the handle is in the open position.The device history records were reviewed and found no related non-conformances were noted for lot numbers ns8332345, or ns8332345xx.A search of complaint records revealed this is the only complaint associated with complaint lot numbers ns8332345, or ns8332345xx.According to the precaution section of the instructions for use (ifu) that accompanies this device: 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 complaint device was found to have a basket that would not open due to sheath damage.The sheath was damaged and separated near the handle, preventing the basket from functioning.All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open.The condition of the returned device makes it possible that it was inadvertently damaged during handling / use.The ifu contains cautions about manipulating the device to prevent damage.Since no information related to product handling is available, a definitive cause could not be established.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.

• 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: 7681396
• Report Number: 1820334-2018-02050
• Device Sequence Number: 1398974
• Product Code: FFL
• UDI-Device Identifier: 00827002179400
• UDI-Public: (01)00827002179400(17)201030(10)NS8332345XX
• Combination Product (Y/N): N
• 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): 09/07/2018

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: 10/30/2020
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: NS8332345XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1