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 Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # - exempt.(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 when the perc ncircle nitinol tipless stone extractor arrived to the client, it was noted to be defective prior to opening packaging.There was no patient involvement.
Additional Manufacturer Narrative
A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, quality control data, and specifications.One unopened package containing a perc ncircle nitinol tipless stone extractor was returned for investigation.The packaging confirms complaint device lot number 9019691.The device was returned in an unopened sealed package.Visual examination found the basket formation has a broken wire.The broken wire has a void.All four wires in the basket formation appear curved/bent.Functional testing noted the handle actuates the basket formation.A review of the device history record found there were no non-conformances related to this reported failure.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number 9019691.The instructions for use (ifu) states the proper warnings, precautions, and instructions for use.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 returned device was packaged in an unopened pouch, indicating the basket was broken when received by the customer.The likely cause for the observed deformed / broken basket wires is that an issue occurred in the manufacturing process that caused the damage.The investigation conclusion is cause traced to manufacturing; manufacturing deficiency.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new information received since the last report was submitted.

• 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: 7942436
• Report Number: 1820334-2018-02778
• Device Sequence Number: 16728923
• Product Code: FFL
• UDI-Device Identifier: 00827002328624
• UDI-Public: (01)00827002328624(17)210716(10)9019691
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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 Expiration Date: 07/16/2021
• Device Catalogue Number: NTRSE-100038
• Device Lot Number: 9019691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1