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

Catalog Number NTSE-022115-UDH

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

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 distributor reported during a flexible ureteroscopy procedure using the ncircle tipless stone extractor, it was noticed that the basket was ruptured.The product was replaced to proceed with the surgery.According to the information provided, no part of the device was left in the patient¿s body.There was no need for any additional procedures.This issue did not cause or contribute to any adverse effect to the patient.

Manufacturer Narrative

Additional event details received.The initial description "the basket was ruptured" was clarified.It was explained that during the procedure while removing the stone, one of the wires broke on the basket, while it was being opened and closed.The wire did not separate from the device.A storz x2 scope and odyssey 30 laser were also in use during this event.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 performed.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation is in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A visual examination noted a kink in the basket sheath 13 cm from the distal tip.A functional test noted the handle actuates the basket formation.One of the basket wires was noted to be pulled out of the cannula; the other three wires were found to be secure.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 no non-conformances were noted that would be related to the reported failure mode.A review of complaints complaint to be the only reported complaint associated to the complaint lot number ns7355116.Based on the provided information a definitive root cause cannot be established at this time.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
• MDR Report Key: 6903391
• MDR Text Key: 87734776
• Report Number: 1820334-2017-03425
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002187788
• UDI-Public: (01)00827002187788(17)191013(10)NS7355116
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXIBLE URETHEROSCOPE; FLEXIBLE URETHEROSCOPE