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

Catalog Number NTSE-022115-UDH

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

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 ureteroscopy with fulguration procedure the ncircle tipless stone extractor basket was tested successfully prior to use.As reported, there was no stone to be removed.The basket was passed one time and a blood clot was pulled out.When attempting to use the basket again for the second time and before patient contact the basket would not fully open.There was no unintended portion of the device left inside the patient¿s body.The procedure was completed by opening and using a new ncircle tipless stone extractor.As reported, there were no adverse effects 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, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned in used condition with the handle in the closed position and the basket formation in the closed position.The collet knob is tight and secure.The male lure lock adaptor (mlla) is finger tight.The polyethylene terephthalate tubing (pett) measures 2.7 cm in length.The mlla was tightened and the basket formation still does not open fully.The length of the basket sheath is 115.2 cm.The length of the basket formation that sticks out is approximately 1 cm.There are a few minor bends in the basket sheath that were visibly noted, possibly from how the device was returned for investigation.The basket sheath does have a couple of significant kinks, one at 21 cm from the support sheath and another at 22 cm from the distal tip of the support sheath.The width of the basket formation is 4 mm.A functional test noted the handle actuates the basket formation, but not to the fully open position.The length of the basket formation is 7 mm.The handle was disassembled.The basket formation could be manually actuated to the fully open position.The handle was reset and reassembled and the device then functioned as intended.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 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.The device history record was reviewed and noted there were ten non-conforming items identified during manufacturing.Nine of the non-conforming items were scrapped.One non-conforming product was reworked.This item was identified to have a component, displaced in package.A review of complaint history revealed this is the only reported complaint associated with the complaint lot number 7850665.Based on the provided information a definitive root cause could not be established.Per the quality engineering risk assessment, no further action is required.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: 6768215
• MDR Text Key: 81852919
• Report Number: 1820334-2017-02291
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)200421(10)7850665
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• 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?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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