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

Catalog Number NGE-022115

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 05/02/2018

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 that one wire come out of the ngage nitinol stone extractor during a retrograde intrarenal surgery (rirs).The patient outcome has not been made available as of yet.A follow up report will be submitted should additional relevant information become available.

Event Description

One wire came out of basket during the retrograde intrarenal surgery (rirs) procedure.After this the doctor broke the stone into small fragments with a laser fiber and the procedure was completed.The patient did well and no additional procedures were required.

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, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open 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 visual examination noted the support sheath is bowed in appearance.There were no kinks noted in the basket sheath.A functional test noted the handle actuated the basket formation.The basket formation was noted to have one of the basket wires pulled out of the cannula.The basket formation has an asymmetrical appearance.The device history record was reviewed and found no non-conformances associated with the complaint device lot number 8028125.A review of complaint history revealed this is the only complaint reported on the complaint device lot 8028125 for this failure mode.There is one additional complaint for an unrelated issue.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 with one of the wires pulled free.The wire had pulled out of the tubing that forms the basket and was not cut or broken.No damage or defect was noted with the tubing.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use of the device.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.

• 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: 7515061
• MDR Text Key: 108358280
• Report Number: 1820334-2018-01473
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)200629(10)8028125
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 61