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

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event is currently under investigation.A follow up report will be provided upon conclusion.
Event or Problem Description
It was reported that the customer had two baskets from the same lot number that only opened on one side.They were used during different holmium laser with lithotripsy procedures on the same day.Only one of the devices is available to be returned.There were no adverse effects to either patient reported.There was no further information provided for either patient.
Additional Manufacturer Narrative
A review of the complaint history, device history, and qc were completed, and visual inspection of the returned device was conducted during the investigation.Two devices were returned for investigation.Device 1 - the product was returned with the unidex (udh) handle and the basket formation in the open position.A functional test was performed and the udh handle actuated the basket formation to the open and closed positions appropriately.Device 2 - a visual examination noted the basket sheath was kinked 69.2 cm from the distal tip.A functional test was performed and the handle actuated the basket open and closed leaving approximately 1mm protruding from tip of basket sheath.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 10 nonconformances for difficulty advancing through sheath, which were not related to the complaint condition.There were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: NCIRCLE TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6383492
• Report Number: 1820334-2017-00437
• Device Sequence Number: 10892920
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)190722(10)7142093
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1