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

Model Number G48297

Device Problem Mechanical Jam (2983)

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

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: other healthcare professional.Pma/510k # exempt preamendment.(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 is reported that while preparing for an unstated procedure using a ngage nitinol stone extractor, the device was tested before use.When tested, the basket would open but would not close.This device was not used.A second basket was used to complete the case.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

No new event information has been provided.

Manufacturer Narrative

Investigation/evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.The device was returned with the handle in the closed position and the basket formation in a partially closed position.Visual examination noted a kink in basket sheath 99.2 cm from the distal tip.There is a slight bow in the support sheath.Functional testing determined the handle actuates the basket formation to the open position, but does not close the basket formation completely.The handle was reset and reassembled and handle functioned correctly.A review of the device history record revealed there are no non-conformances associated with the complaint device lot that would cause or contribute to the reported failure mode.A review of complaint history shows this is the only complaint associated with the complaint device lot number.The instructions for use (ifu) provides the following information to the user related to the report failure mode.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.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 and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The returned device was found to not fully close.The sheath was kinked approximately 99 cm from the distal end, and there was a slight bow in the yellow support sheath.It was possible that the observed sheath damage prevented the basket from properly closing.The cause for the failure of the device to close properly could not be conclusively determined.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor 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: 8443367
• MDR Text Key: 139575417
• Report Number: 1820334-2019-00665
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482975
• UDI-Public: (01)00827002482975(17)220129(10)9482012
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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 Expiration Date: 01/29/2022
• Device Model Number: G48297
• Device Catalogue Number: NGE-022115
• Device Lot Number: 9482012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1