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

Catalog Number NGE-017115-MB

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510k # ¿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, when the ngage nitinol stone extractor was removed from the container prior to a ureteroscopy, the basket snapped in half where the wire meets the handle.This happened while prepping for a ureteroscopy.A new device was opened and used for the procedure.No patient involvement.

Manufacturer Narrative

Investigation ¿ evaluation: the device was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A search of the north american distribution center database shows that all devices from lot 8771488 have been shipped.Therefore, 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 no non-conformances associated with the complaint device lot number.A review of complaint history found no other complaints associated with complaint device lot number 8771488.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 reported to have a sheath that separated near the handle.It is likely the device was damaged when removing it from the packaging.The instructions for use (ifu) contains cautions about manipulating the device to prevent damage.The likely cause for this issue was product use or handling related - product received excessive pressure.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

It was reported, when the ngage nitinol stone extractor was removed from the container prior to a uteteroscopy, the basket snapped in half where the wire meets the handle.This happened while prepping for a ureteroscopy.A new device was opened and used for the procedure.No patient involvement.

• 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: 7625933
• MDR Text Key: 112200957
• Report Number: 1820334-2018-01831
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482951
• UDI-Public: (01)00827002482951(17)210413(10)8771488
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2021
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 8771488
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1