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

Catalog Number NTSE-015115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

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 Description

The user facility reported during a ureteroscopy kidney stone extraction procedure, the ncircle tipless stone extractor basket was not opening and closing completely.The nitinol wire seemed to stretch in length and was getting thinner and the outer sheath broke off from the handle.Another ncircle tipless stone extractor was used to complete the procedure.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Evaluation / investigation: a visual inspection 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 partially opened and the basket formation is closed.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2.5 cm.A visual examination noted the support sheath and the basket sheath are detached.Adhesive is visible on the basket sheath.The device history record was reviewed and found there were no non-conformances noted.A review of complaint history revealed that this is the only complaint associated with device lot number 8190345.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.Based on the provided information a definitive root cause cannot 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: NCIRCLE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7128221
• MDR Text Key: 96022104
• Report Number: 1820334-2017-04600
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)200901(10)8190345
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1