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

Catalog Number NGE-017115-MB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(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 that the user opened the package of a ngage nitinol stone extractor and checked the integrity of the device and discovered the basket cannot be fully closed or released.No patient involvement.

Manufacturer Narrative

Investigation - evaluation: visual inspection and functional testing of the returned device was conducted during the investigation.A review of complaint history, the device history record, instructions for use, and quality control data was also performed.One device was returned for investigation.The device was returned with the handle in the open position.The basket formation was returned partially open and there is a gap in the basket formation.The collet knob is tight and secure.The male luer lock adapter (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.A visual examination noted the basket sheath is kinked 1 mm from the support sheath.A functional test noted the handle does not actuate the basket formation.A closer observation noted the kink on the basket sheath is severed with the weave exposed.Also, the clear sheath covering the basket wires is wrinkled.The device history records were reviewed and found no non-conformances that would have contributed to the reported failure mode.A review of complaint history revealed this is the only complaint associated with lot number 8407495.The instructions for use (ifu) provides the following: suggested handling instructions for extractors and forceps 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.Devices are inspected for damage and functionality prior to packaging.The complaint device was found to have a basket that would not fully open and close due to sheath damage.The sheath was found to be kinked near the handle.The kink prevented the basket subassembly from moving freely within the sheath when the handle was operated.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling of the device.The ifu contains cautions about manipulating the device to prevent damage.The likely cause for this issue was product use or handling related ¿ the 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 that the user opened the package of a ngage nitinol stone extractor and checked the integrity of the device and discovered the basket cannot be fully closed or released.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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7615064
• MDR Text Key: 112336870
• Report Number: 1820334-2018-01838
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482951
• UDI-Public: (01)00827002482951(17)201130(10)8407495
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: NGE-017115-MB
• Device Lot Number: 8407495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1