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 Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(b)(4).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 the wires disconnected from the tip of the ngage nitinol stone extractor basket while attempting to retrieve stones during a ureteroscopy.As reported, this issue occurred with three devices in the same case.The procedure was successfully completed with the use of a fourth device.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Investigation ¿ evaluation: the ngage nitinol stone extractor has not been returned and no photographs were provided.Therefore, a physical examination could not be performed.A document based investigation has been performed.The investigation included a review of the instructions for use and quality control data.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.Current controls are in place in manufacturing to assure device functionality prior to shipping.A review of the device history record could not be performed as the device lot number was not provided.The complaint history for the complaint product and lot number combination could not be reviewed as the lot number is unknown.The following warnings are contained in the instructions for use (ifu): caution: this device is conductive.Avoid contact with any electrified instrument.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.The cause of the reported failure could not be determined with the information available.Per the quality engineering risk assessment, no further action is warranted.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: 7369982
• MDR Text Key: 103548286
• Report Number: 1820334-2018-00806
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115-MB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1