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

Catalog Number NGE-017115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that the basket on the ngage nitinol stone extractor did not close entirely.Issue was found while testing the device prior to usage.Another stone extractor was used for the procedure.No patient involvement.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, drawings, manufacturing instructions, quality control data and specifications.A visual inspection and functional testing of the returned device was also conducted during the investigation.One device was returned for investigation.The device was returned with the handle in the closed position.The basket formation was in the closed position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3.5 cm in length.A functional test determined the handle opens the basket formation completely; but does not close completely.A visual examination noted there is a gap in the basket wires when the basket formation is in the closed position.From the investigation photos, it appears 1 of the basket wires is slightly pulled out from base of the basket assembly.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history found this to be the only complaint associated with product lot number 6884344.All devices are 100% inspected for functionality and integrity before packaging.The instructions for use (ifu) contains a caution, "do not use excessive force to manipulate the device, or damage to the device may occur.The amount of force applied to the device is unknown.With the available information, the root cause of the event could not be determined." measures have been initiated to address this 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: 7150862
• MDR Text Key: 96125622
• Report Number: 1820334-2017-04343
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)190412(10)6884344
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/22/2018
• Patient Sequence Number: 1