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

Catalog Number	NTSE-022115-UDH-MB
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 flexible ureteroscope lithotripsy procedure, the ncircle tipless stone extractor basket would not grab patient's stone.It was stated the head of the basket was defective.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.
Additional Manufacturer Narrative
Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 1.5 cm.A visual examination noted a kink in the basket sheath 38 cm from the distal tip of the basket sheath.A functional test noted the handle does not actuate the basket formation.The basket formation was found to appear collapsed.The knot at the end of the basket formation has come loose.The device history record was reviewed and found there were three non-conformance issues noted.Three items found with basket shape incorrect, three failed test, tensile, non-destructive and one item with labels applied incorrectly.A review of complaint history revealed that this is the only complaint associated to lot number 8170355.Based on the investigation evaluation, 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.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A definitive root cause cannot be established with the information available.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: 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: 7070167
• Report Number: 1820334-2017-04192
• Device Sequence Number: 1798261
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)200825(10)8170355
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 11/29/2017

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-022115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 DA
• Patient Weight: 53