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

Model Number G48296

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, prior to a stone removal procedure using a ngage nitinol stone extractor, there was unknown foreign matter found in the device package.The user checked the device prior to use and discovered black foreign matter inside of the sealed package.The user did not open or use the device.It is unknown how the procedure as completed.No adverse events have been reported as a result of the alleged malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Event Description

No additional patient or event information has been received since the last report was submitted on (b)(6) 2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned, but two pictures of the device were provided.The pictures show a large amount of black foreign material covering the device packaging.The material is especially heavy on the back side of the packaging.No physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The complaint device was not returned, but two pictures of the device were provided.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.The complaint device was not returned.Two pictures provided by the customer show a large amount of black foreign material covering the packaging.The material is especially heavy on the back side.Material can be seen on the clear portion of the packaging film, but without the device returned, it could not be determined if the foreign material was inside the packaging, or located on the outside.The packaging of the device is inspected twice for particulate before shipping, once during the sealing operation and once during quality control checks.The large amount of foreign material on the packaging makes it highly unlikely that the material was present during the packaging or quality control operations.Although the user stated the material was inside the packaging, without the device returned, it is possible the material was only located on the outside of the package, but appeared to be on the inside because of the clear plastic portion of the pouch.Based on the available evidence, the most likely cause for the black foreign material found on the packaging is that during transportation or storage the packaging was exposed the foreign material.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 9008249
• MDR Text Key: 157794526
• Report Number: 1820334-2019-02276
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482968
• UDI-Public: (01)00827002482968(17)220129(10)9484181
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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: G48296
• Device Catalogue Number: NGE-022115-MB
• Device Lot Number: 9484181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1