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

Catalog Number	NGE-022115-MB
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient code: no consequences or impact to patient.Device code: mechanical issue, difficult to open or close is not labeled.Method codes: device not returned.Conclusion codes: cause not established.Investigation ¿ evaluation the complaint device was not returned for an evaluation and no photographs were provided.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, manufacturing instructions, and quality control data.A search of the north american distribution center database shows all devices from lot 7087538 have been shipped.No similar product from the same lot is available for investigation.The device history records were reviewed for lot number 7087538.It was noted 3 devices from the lot were scrapped due to the baskets not closing completely.A review of complaint history records revealed there is one additional complaint for a similar issue associated with lot number 708751.Per the instructions for use (ifu): caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.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 manufacturing process for nge devices is individual in nature and each one is tested multiple times during manufacturing and before packaging to ensure device functionality.There are multiple possible causes for the failure of the baskets to close properly: ¿ the devices becoming damaged during handling / use.¿ procedural issues such as a tortuous path affecting the ability of the basket to close.¿ manufacturing issues resulting in reduced ability of the device to function properly during use.Without the devices available for investigation, the cause for the reported issue could not be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It was reported during a ureteroscopy with lithotripsy, two ngage nitinol stone extractors weren¿t closing properly.Upon follow up with the physician for additional information, the doctor replied that both ngage¿s did not function properly.He used a competitor¿s basket to finish the case.No intended part of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.There was no adverse effect to the patient.

• Brand Name: NGAGE NITINOL 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: 7878259
• Report Number: 1820334-2018-02709
• Device Sequence Number: 10797169
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)190630(10)7087538
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/14/2018

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: 06/30/2019
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 7087538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1