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

Catalog Number NGE-017115

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/14/2018

Event Type  malfunction  

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.

Event Description

It was reported the ngage nitinol stone extractor basket did not open out.Additional information has been requested regarding the device and event.At the time of this report filing, no additional information has been forthcoming.

Event Description

It was reported the ngage nitinol stone extractor basket did not open out.The following additional information has been obtained: this event occurred during a cystoscopy and laser of stones procedure.During stone retrieval in the patient's bladder, although the device had been tested prior to use and it worked, it didn't work while in the patient's bladder.They opened another retrieval device which worked.There were no adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the ngage nitinol stone extractor was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.All devices from lot 8692435 have been shipped.No similar product from the same lot is available for investigation.A document based investigation was performed.A review of complaint history, the device history record, instructions for use, and quality control data was conducted.A review of the device history record found there are no non-conformances that may have contributed to this incident.A review of complaint history revealed this the only complaint associated with lot number 8692435.The instructions for use (ifu) includes the following information: 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 ngage nitinol stone extractor was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed and the complaint was not able to be confirmed.Measures have been initiated to address the reported failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7564838
• MDR Text Key: 109994996
• Report Number: 1820334-2018-01579
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)210326(10)8692435
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Catalogue Number: NGE-017115
• Device Lot Number: 8692435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1