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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the user facility that during preparation for an ureteroscopy / ureterorenoscopy procedure.The ncircle delta wire tipless stone extractor would not function as tended.When the lever was pushed to open/close on the basket, the entire basket moved forward and backwards at the distal end of fiber, rather than opening and closing the basket.However, due to no patient contact, no adverse effects or medical intervention is warranty at this time.No further information was provided.

Manufacturer Narrative

Evaluation - a review of the complaint history, functional tests, device history review, quality control, visual inspection and device analysis of the returned devices was conducted during the investigation.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.Two devices were returned for investigation.For the first device evaluated, the device was received with the handle in the closed position and the handle in the open position.In the closed position, the coil assembly extended beyond the end of the basket sheath.No kinks were noted in the basket sheath.A functional test was performed and the udh handle does not actuate the basket formation.The support sheath and basket sheath were found to be separated from one another.The second device evaluated, the device was returned in the closed position and the basket formation was in the open position and extended beyond the end of the basket sheath.The coil assembly was found to have a kink away from the basket formation.A functional test was performed and the udh handle does not actuate the basket formation.The support sheath and basket sheath were found to be separated from one another.A review of the non-conformance data revealed no non-conformances related to the work order.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NCIRCLE DELTA WIRE 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6391036
• MDR Text Key: 69574784
• Report Number: 1820334-2017-00425
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191105
• UDI-Public: (01)00827002191105(17)191230(10)7557448
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: NTSED-024115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1