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

Catalog Number NTSE-022115-UDH

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

It was reported that the basket broke on a ncircle tipless stone extractor while in use.No adverse events have been reported as a result of the alleged malfunction.Request for additional information regarding lot number, patient information, date of event, and procedure being performed have been made, however, the customer has not provided any further information.

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 partially open.The collet knob is tight and secure.The mlla (male luer lock adaptor) is loose.The pett measures 3 cm in length.The support sheath and basket sheath are still adhered.A functional test determined the handle does not actuate the basket formation.A visual examination noted the tip of the basket sheath is smashed approximately 1 mm from the distal tip.There is a small kink 47.2 cm from the distal tip.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, no product returned, 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
• 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: 7151792
• MDR Text Key: 96124132
• Report Number: 1820334-2017-04587
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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