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

Catalog Number NTSE-030115-UDH

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

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

It was reported during a transurethral uretero-lithotripsy procedure, the ncircle tipless stone extractor was not opening.They proceeded with another device and completed the procedure successfully.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

It was reported during a transurethral uretero-lithotripsy procedure, the ncircle tipless stone extractor was not opening.There were no problems in the patient's anatomy.A ureteroscope was inserted into the patient and stone and in the urinary duct the stone broke.After two or three attempts of stone retrieval, the basket became impossible to open.Another device was used to complete the procedure successfully.

Manufacturer Narrative

Blank fields on this form indicate the information are unknown, unavailable or unchanged.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.The returned device was found to be non-functional due to sheath damage near the distal end.All devices are 100% inspected for functionality and integrity before packaging.It is likely the sheath of the device became damaged during handling of the device.The device history record was reviewed and no non-conformances were noted.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.The investigation was not able to conclude a cause of the event.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
• MDR Report Key: 7147326
• MDR Text Key: 96063681
• Report Number: 1820334-2017-04601
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2018

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-030115-UDH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/11/2018; 01/31/2018
• Supplement Dates FDA Received: 01/24/2018; 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1