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

Model Number G48294

Device Problem Break (1069)

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

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported, prior to use of an ngage nitinol stone extractor, it was observed that the basket wire was broken.No adverse events have been reported as a result of the alleged malfunction.

Event Description

There is no new patient or event information to report since the last mdr submission on (b)(6) 2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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, device history record, the 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.Inspection of the returned device noted the device was returned with the device handle and basket formation in the open position.The support sheath was bowed.Kinks were identified in the basket sheath 28 cm, 73.5 cm, and 88.5 cm from the distal tip.One wire in the basket formation was broken, with discoloration being noted at the points of separation.One wire appeared to have been pulled on and stretched.Functional testing noted that the handle actuates the basket formation.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.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 instructions for use (ifu) provides the following information to the user related to the reported failure mode: 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 returned device was found to have had 1 of 3 basket wires broken.The support sheath was bowed.Kinks were identified in the basket sheath 28 cm, 73.5 cm, and 88.5 cm from the distal tip.One wire in the basket formation was broken, with discoloration being noted at the points of separation.One wire appeared to have been pulled on and stretched.The condition of the retuned device indicates the device was possibly used, but the information provided stated that the device was not used and the broken wire was discovered before use.All device are inspected multiple times during manufacturing and quality control checks for damage and to ensure functionality.The cause for the broken wire could not be determined.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.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: 8890704
• MDR Text Key: 154730348
• Report Number: 1820334-2019-02008
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)211115(10)NS9314310
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: 11/15/2021
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: NS9314310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1