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

Model Number N/A

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 08/02/2017

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 that while the physician was performing an unspecified procedure on a patient using an ncircle tipless stone extractor device.The physician discovered that the device broke in the middle of the procedure.The physician further stated that the ureteroscope was damaged as there was a leak after the procedure.Additional information was requested; however it is not available at this time.

Manufacturer Narrative

Investigation - evaluation: a review of device history record, documentation, specification, instructions for use (ifu), complaint history, and visual inspection of the returned device was conducted during on the returned product during the investigation.No issues were found related to the reported complaint.One device was returned for investigation.The device was returned with the handle in the open position.It was observed that the basket sheath and coil has been severed from the nose of the male luer lock adapter (mlla).A visual examination noted that the basket coil was extended beyond point of separation.The support sheath was found bowed in appearance.A severe kink was noted 4cmfrom the point of separation on the basket sheath.The mlla was found finger tight.The collet knob was found tight and secure.The handle actuated what is left of the basket coil.The distal tip appears curved and is smashed.The points of separation appeared cut.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.Review of the device history record of the finished product shows no nonconforming events that would contribute to the reported failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation; a definitive root cause could not be determined.Measures have been initiated to correct this issue.Monitoring will continue to be performed 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: 6800433
• MDR Text Key: 82946008
• Report Number: 1820334-2017-02519
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)191220(10)7535372
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• 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: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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