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

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

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

The customer reported that, when the operator went to use the ngage during a ureteroscopy, the device would not close.Another basket was used to complete the case.No adverse effects were reported as a result of the issue.

Manufacturer Narrative

Investigation- summary: a review of the complaint history, device history record, specifications, quality control and visual inspection of the returned device was conducted.One ngage nitinol stone extractor (lot7750614) was received for evaluation.The device was returned with the handle in the closed position and the basket formation was partially closed.A visual examination noted the support sheath was bowed.Kinks were noted in the basket sheath at 1.5 cm from distal tip, 87 cm from the distal tip, and 109 cm from the distal tip.The collet knob was tight and secure.The male luer lock adaptor (mlla) was tight.The polyethylene terephthalate tubing (pett) measured 3.5 cm in length.A functional test was performed.The unidex (udh) handle actuated the basket formation to the open position without issue; but with the udh handle in the closed position, the basket formation did not close completely.The wires had the appearance of being pulled on.The customer complaint was confirmed.There was 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 were noted.A review of complaint history for the product lot revealed this complaint to be the only reported complaint associated to complaint lot number 7750614.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing and quality controls that may have contributed to this incident.Based on the available information and the investigation of the returned device a definitive root cause of this device issue could not be determined and no conclusion can be drawn.Measures have been initiated to address this failure mode.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6732524
• MDR Text Key: 80694873
• Report Number: 1820334-2017-01809
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)200315(10)7750614
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NGE-022115-MB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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