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	07/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: optilite single-use holmium laser fiber, storz endoscope, and universa soft n/a ureteral stent set.Pma/510k #: 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 reported, during a ureterolithotripsy procedure, after the doctor broke the stone, he introduced the nforce nitinol helical stone extractor and removed some fragments.When he re-introduced the extractor, the basket did not close.Another extractor was opened to finish the procedure.No adverse events have been reported as a result of the alleged malfunction.
Event or Problem Description
There has been no new information received 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, the device history record, drawings, instructions for use, manufacturing instructions, quality control data, and specifications.One nforce nitinol helical stone extractor was returned for investigation.The device was returned with the handle and the basket formation in the open position.The male luer lock adapter (mlla) is tight.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 1.5 cm in length.Functional testing determined the handle does not actuate basket formation.Visual examination noted when the basket sheath is accordion/buckled starting 4 cm from distal tip of support sheath.With the handle in the closed position, the basket formation protrudes 6 mm from the basket sheath.The support sheath and basket sheath are detached.A review of the device history record found there were no non-conformances related to this reported failure.A review of complaint history records revealed one other complaint associated with the complaint device lot number 8390930.According to the instructions for use (ifu): precaution section: 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.All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open.The ifu contains cautions about manipulating the device to prevent damage.The complaint device was found to have a basket that was open and could not be closed fully due to sheath damage.The sheath damage prevented the motion of actuating the handle from opening / closing the basket.The cause of the observed damage 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.

• 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: 8025523
• Report Number: 1820334-2018-03240
• Device Sequence Number: 1755472
• Product Code: FFL
• UDI-Device Identifier: 00827002179400
• UDI-Public: (01)00827002179400(17)201121(10)8390930
• 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): 11/15/2018

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: 11/21/2020
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: 8390930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1