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

Catalog Number NTSE-022115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2017

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 flexible ureterorenoscopy procedure, the ncircle tipless stone extractor basket was unable to open.The user proceeded to open and close the basket but the device was not functioning as expected.There was no patient contact.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.The basket formation was 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 approximately 3 cm.A functional test determined the handle does not actuate the basket formation.A visual examination noted a small kink in the basket sheath 72 cm from the distal tip of the basket sheath.The support sheath and basket sheath are still adhered.The basket formation is flat in appearance.The basket wires look to be crossed.The handle was disassembled.The basket assembly can be pushed out but cannot be pulled back into sheath.Glue was noted to be on the basket cannula, which most likely aids in the difficulty.The device history record was reviewed and noted one non-conformance for 5 items that were difficult to advance through the sheath.These items were scrapped.A review of complaint history revealed that this is the only complaint that has been received on this device complaint lot 7824004.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 the root cause can be attributed to a manufacturing error due to excessive glue found in the basket cannula.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7113204
• MDR Text Key: 95332921
• Report Number: 1820334-2017-04423
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200412(10)7824004
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1