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

Catalog Number NGE-022115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported the ngage nitinol stone extractor basket could not close completely.No patient involvement.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of functional testing, drawings, manufacturing instructions, specifications, quality control data, and visual inspection of the actual device was conducted during the investigation.One device was returned for investigation.The device was returned with the handle between the open and closed position.The basket formation is in the open position.A visual examination noted the basket sheath has a kink from the distal tip and appears to have scrapes marks as well.There are also multiple kinks from the distal tip of the basket sheath and again at the distal tip of the support sheath.A functional test determined the handle will actuate the basket formation to the open position, but it is slow to close.It does eventually close completely.After several actuations, the basket open and closed fine.The device appeared to have debris at the tip, but once the debris was pushed out, the device functioned fine.It was determined that there are no other complaints for this lot number.A definitive cause cannot be established at this time.There is no evidence to suggest the product was not made to specifications.Measures have been previously initiated to address this issue and per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor 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: 7147711
• MDR Text Key: 95921348
• Report Number: 1820334-2017-04610
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)200626(10)8016822
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-022115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1