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

Catalog Number	NTRSE-120038
Medical Device Problem Codes	Device Operational Issue (2914); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the perc ncircle nitinol tipless stone extractor basket appears to not open or even extend properly from the distal end.There were no adverse consequences or effects to the patient reported.No further information has been forthcoming despite multiple attempts to obtain patient, device and event details.
Additional Manufacturer Narrative
Investigation - evaluation: visual inspection and functional testing of the returned device was conducted during the investigation.A review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.A functional test determined the device fails to actuate.The basket assembly would not move.There were no kinks or damage to the sheath.The basket was able to be opened using a large amount of force.Once open, the basket would not retract when the handle was released.The cause for the handle sticking and preventing proper operation of the basket could not be determined.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls are in place in manufacturing to assure device functionality prior to shipping.The device history record was reviewed and found there were no non-conformances associated with the complaint device lot number.A review of complaint history revealed this is the only complaint report associated with complaint device lot number 7889809.Based on the provided information a definitive cause issue could not be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: PERC NCIRCLE NITINOL 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: 7288700
• Report Number: 1820334-2018-00452
• Device Sequence Number: 14028731
• Product Code: FFL
• UDI-Device Identifier: 00827002272347
• UDI-Public: (01)00827002272347(17)200505(10)7889809
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/18/2018

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 Catalogue Number: NTRSE-120038
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1