MAUDE Adverse Event Report: COOK INC NFORCE NITINOL HELICAL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number	NFHSES-032115-3W-UDH
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
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, before the procedure the extractor was tested.The basket did not work and handle was broken.No adverse consequences to the patient have been reported.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Investigation/evaluation: the complaint device was not received for an evaluation.A search of the north american distribution center database shows all devices from lot: 8301889xx have been shipped.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and quality control data.A review of the device history record revealed there are three lots associated with the devices for this complaint: lot: 8301889, lot: 8301889x, and lot 8301889xx.: thirty-seven devices from lot: 8301889 were reworked through lots: 8301889x and 8301889xx so that the trays of the devices could be replaced due to an issue with the lid of the trays not closing properly.This issue was unrelated to this complaint.Two non-conformances were identified that could have a relationship to the reported complaint.Lot: 8301889xx, non-conformance; handle broke (qty 3).Lot: 8301889, non-conformance; basket/grasper will no open/close (qty 8).These non-conforming items were scrapped.A review of complaint history records revealed this complaint is the only one associated with any of the related complaint lot numbers lot: 8301889, lot: 8301889x, or lot: 8301889xx.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.All devices are inspected for functionality and damage prior to packaging and are packaged with the basket open.He complaint device was not returned so it could not be determined if the non-conformances identified during production were in any way related to the failure of the complaint device.Without a device evaluation, the cause of the reported issue could not be determined.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.

• Brand Name: NFORCE NITINOL HELICAL 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: 8152419
• Report Number: 1820334-2018-03679
• Device Sequence Number: 11205035
• Product Code: FFL
• UDI-Device Identifier: 00827002179400
• UDI-Public: (01)00827002179400(17)201018(10)8301889XX
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 01/14/2019

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: 10/18/2020
• Device Catalogue Number: NFHSES-032115-3W-UDH
• Device Lot Number: 8301889XX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1