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

Catalog Number NTSE-030115-UDH

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown as information not provided by reporter.Blank fields on this form indicate the information is unknown or unavailable.(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 by the area representative that during preparation for an ureteroscopy procedure, after the package was opened containing the ncircle tipless stone extractor, it was found that the tip of the handle could not be moved.The device was not used.This device did not make patient contact.The patient did not require any additional procedures because of this device issue.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Evaluation / investigation: a visual inspection 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.A visual examination noted the support sheath and basket sheath are detached.There is 2.5 cm of coil exposed from the distal end of the support sheath.The collet knob is tight and secure.The male lure lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length.A kink is noted in the basket sheath 8.2 cm from the distal tip of the basket sheath.Also returned with the stone extractor were a pin vise and a 10 cc syringe, neither of which is sold with the device.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 no non-conforming items identified during manufacturing.A review of complaint history revealed this is the only reported complaint associated with the complaint lot number ns7134996.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: 6857407
• MDR Text Key: 85907384
• Report Number: 1820334-2017-02868
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002176270
• UDI-Public: (01)00827002176270(17)190720(10)NS7134996
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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