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

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that the physician was performing an ureterorenolithotripsy procedure by using an nforce nitinol helical stone extractor device.The physician noticed that the basket of the device would not close properly.It was further reported that the physician had to cut catheter to remove the device from the patient.The product was replaced and the intended procedure was completed successfully.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was requested from the customer.
Additional Manufacturer Narrative
Investigation ¿ evaluation; the nforce nitinol helical stone extractor was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation was performed.A review of complaint history, the device history record, documentation, instructions for use, and specifications was conducted.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record found four non-conformances associated with the complaint device lot number 6993780.All four non-conforming devices were scrapped.A review of complaint history for the device lot found one other complaint associated with the device lot number 6993780.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A 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.Based on the provided information and the investigation evaluation the root cause of this event is undeterminable.Per the quality engineering risk assessment, no further action is required.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: 6829594
• Report Number: 1820334-2017-02689
• Device Sequence Number: 1600959
• Product Code: FFL
• UDI-Device Identifier: 00827002190726
• UDI-Public: (01)00827002190726(17)190524(10)6993780
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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 Model Number: N/A
• Device Catalogue Number: NFHSES-022115-3W-UDH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1