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

Catalog Number	NTRSE-100038
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.The alleged device has been returned and an evaluation is in process.
Event or Problem Description
It was reported the perc ncircle nitinol tipless stone extractor was opened and tested prior to use when the basket was found to be twisted.Another like device was used for the scheduled procedure.There were no adverse consequences to the patient as a result of this reported issue.The device was not used.
Additional Manufacturer Narrative
Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, instructions for use, and quality control data was also performed.One device was returned for investigation.A visual examination of the returned device noted the basket formation appeared flat.The loop has pulled apart and the wires are twisted.A functional test determined the handle actuated the basket formation.A review of the device history record revealed one non-conformance issue during manufacturing that involved three items with a wrinkled seal.The three non-conforming items were scrapped.A review of complaint history for this device lot revealed there has been no other complaint associated with lot number 8400533.The instructions for use (ifu) provides the following relevant information: important: enclose device in sheath before removing from tray/holder important: excessive force could damage device.A review of relevant manufacturing documents was conducted.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.The complaint device was found to have a twisted basket.The knot that holds the two basket wires was found to have become undone.Devices are inspected for damage and functionality prior to packaging.It is possible that handling of the device damaged the basket before use.Per the quality engineering risk assessment, no further action is warranted.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: 7369324
• Report Number: 1820334-2018-00697
• Device Sequence Number: 555196
• Product Code: FFL
• UDI-Device Identifier: 00827002328624
• UDI-Public: (01)00827002328624(17)201128(10)8400533
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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-100038
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1