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

Model Number N/A

Device Problems Fracture (1260); Kinked (1339); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported by the user facility that a patient underwent an ureteroscopy procedure.The attending physician attempted to extract a stone using the ncircle tipless stone extractor when the basket kinked in mid procedure and the wire partially detached from the basket.The physician replaced the basket and completed the procedure.No pieces from the detached basket were left in the patient nor did the patient experience any adverse effects or medical intervention due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation - evaluation.A review of complaint history, device history record, specification and quality control data was conducted during the investigation.The device was returned with the udh handle and the basket formation in the closed position.A visual examination noted the basket sheath has a severe kink at the base of the support sheath.A functional test was performed and the udh handle would not actuate the basket formation.There is no indication that a design or process related failure mode contributed to this event.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.Based on the provided information, no conclusion can be drawn hence the root cause is unknown.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment, we have notified the appropriate personnel of this event.No further action is required.Per the risk assessment no further action is required.

• 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: 6331411
• MDR Text Key: 67498385
• Report Number: 1820334-2017-00185
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)190627(10)7078279
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• 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?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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