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

Catalog Number	NTSE-030115-UDH
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
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
The user facility reported during a ureteroscopic lithotripsy procedure, upon retrieval of the patient's stone, the ncircle tipless stone extractor handle and sheath separated.The physician opened a new ncircle tipless stone extractor and completed the procedure successfully.The reporter stated that no section of the device remained inside of the patient's body.Also stated was that there were no adverse events related to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation.A review of functional testing, documentation, drawing, manufacturing instructions, visual inspection, specifications, and quality control data was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation was in the open position.The collet knob is tight and secure.The mlla (male luer lock adaptor) is loose.The pett measures 3 cm in length.A functional test determined the handle actuates the basket formation.There are a few kinks in the basket formation, possibly from the condition the device was returned.Three of the more severe kinks are located at 56.5 cm from the distal tip of the basket formation, again at 60 cm and 60.5 cm from the distal tip of the basket formation.A visual examination noted that two of the basket wires have pulled out of the distal cannula.No patient harm was reported.There is no indication that a design or process related failure mode contributed to this event.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 investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: NCIRCLE TIPLESS 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: 7138709
• Report Number: 1820334-2017-04424
• Device Sequence Number: 16164539
• Product Code: FFL
• UDI-Device Identifier: 00827002176270
• UDI-Public: (01)00827002176270(17)200907(10)8198843
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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 Catalogue Number: NTSE-030115-UDH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/01/2018
• Patient Sequence Number: 1