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

Catalog Number NTSE-022115-UDH

Device Problems Difficult to Remove (1528); Device Operational Issue (2914)

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

Event Date 09/12/2017

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 area representative reported during a ureteroscopy procedure performed on (b)(6) 2017, the ncircle tipless stone extractor was used to retrieve a stone.While in use, the basket broke off at the neck of the basket leaving the basket in the patient.A second ncircle tipless stone extractor was used and it also broke off in the same way.When the third ncircle tipless stone extractor was put into use, it would not work properly and it had to be disassembled to remove it from the patient.This basket did not break off.The procedure could not be completed.The patient had to come back to have basket fragments removed and the ureteroscopy procedure completed.The basket fragments were removed using a different device.There were no adverse effects to the patient during the interventional surgery.Additional event and patient information has been requested.Three related reports have been filed to capture each of the three device malfunctions reported to occur during one procedure.Mfr.Report # 1820334-2017-03515 captures the first basket, mfr.Report # 1820334-2017-03517 captures the second basket and mfr.Report # 1820334-2017-03519 captures the third basket used in the procedure.

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 lot number on the returned device is 8148161.The device was returned with the handle is in the open positions.The collet knob is tight and secure.The male lure lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.The support sheath is bowed.A visual examination noted the basket formation is detached from the coil assembly.The wires in the basket formation have been severed and have the appearance on being pulled.It appears the device met resistance beyond its intended design.The device history record was reviewed and noted there were two non-conformances associated with the complaint device lot number.One nonconformance noted a documentation error that was corrected.The second non-conformance was for identified as basket/grasper retraction depth incorrect.This item was scrapped.A review of complaint history revealed this to be the only complaint report associated with complaint lot number 8148161.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 and device integrity prior to shipping.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 provided information and evaluation, the root cause is possibly related to product use and handling.Measures have been initiated to address this failure mode.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: 6936966
• MDR Text Key: 90058251
• Report Number: 1820334-2017-03519
• 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: 02/15/2018

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-022115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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