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 11/14/2017

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 transurethral ureter-lithotripsy procedure, the physician conducted a functional check of the ncircle tipless stone extractor prior to insertion of the patient's body and discovered that the basket could not open or close.Another stone extractor was used to complete the procedure successfully.No adverse effects or consequences were reported to the patient due to this occurrence.

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 and the basket formation also in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length and was returned on the outside of the cannulated handle.When the handle was actuated, the support sheath and the basket sheath were found to be separated.There is minimal adhesive on the basket formation.No damage was noted on the basket sheath.The basket assembly can be manually actuated.The device history record was reviewed and noted two non-conformances were identified.One issue was related to component, missing and the second issue basket/grasper will not open/close.A review of complaint history revealed this is the only complaint associated with lot number 8164308.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 and device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established at this time.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: 7067483
• MDR Text Key: 93459736
• Report Number: 1820334-2017-04184
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)200823(10)8164308
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1