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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

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 physician was performing a bilateral ureteroscopy procedure on a patient by using the ncircle tipless stone extractor.The physician noticed that the wires of the device did not open completely, only two out of four wires opened.It is not known if the intended procedure was completed.No unintended section of the device remained inside the patient¿s body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Corrected information: report source: health professional, user facility, company representative.Investigation summary: a review of the complaint history, instructions for use(ifu), device history record, documentation and quality control of the returned device were conducted during the investigation.One device was returned for investigation.The device was returned with the handle in the closed position and the basket formation in the open position.The collet knob was found to be loose and barely threaded into the handle.The mlla (male luer lock adaptor) is tight.The polyethylene terephthalate tubing (pett) was not returned with the device.The handle does not actuate the basket formation.The wires were tested and found to be secure in the cannula.The basket sheath and the support sheath are still adhered.A visual examination noted a kink in the basket sheath 90 cm from the distal tip.Coil is exposed from the basket sheath 1.2 cm from the distal tip.The handle was disassembled and the basket formation was found to retract manually using force.It appears the customer may have disassembled the device.The device was shipped with the instructions for use (ifu) which clearly states; under direct visualization, locate the stone and advance the extractor to a location just proximal to the stone.Slide the thumb lever on the handle to the ¿open¿ position to deploy the basket near the stone and maneuver the device until the stone is within the basket.Once correctly positioned, draw the basket down around the stone and slide the thumb lever into the ¿close¿ position.Maintaining position of the stone within the basket, retract the scope and basket." additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found four non-conformances associated with the complaint device lot number which were identified and reworked or scrapped prior to further processing.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: NCIRCLE DELTA WIRE 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: 6728050
• MDR Text Key: 80565844
• Report Number: 1820334-2017-01717
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSED-024115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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