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

Catalog Number NGE-017115

Device Problem Insufficient Information (3190)

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

Event Date 04/30/2018

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 the ngage nitinol stone extractor had a faulty basket.No further information is available at this time; however, follow up with the customer to obtain additional information is currently in process.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.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.A review of relevant manufacturing documents was conducted.It was concluded that the device was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The cause of the reported issue could not be determined with the information available.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.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.A review of relevant manufacturing documents was conducted.It was concluded that the device was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The cause of the reported issue could not be determined with the information available.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7525709
• MDR Text Key: 108643096
• Report Number: 1820334-2018-01318
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1