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

Model Number G48294

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: 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 that during an unknown procedure, prior to opening the pouch of a ngage nitinol stone extractor, the operator discovered the bottom of the pouch was not sealed.It is unknown how the procedure was finished.No adverse effects to the patient have been reported.Additional information has been requested and will be included in a follow-up report when and if that information is received.

Event Description

No additional patient or event information has been received since the last report was submitted.

Manufacturer Narrative

Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.Visual examination of package confirmed the bottom of the package is open on the left corner of the bottom straight seal.The seal was not straight across the bottom, package was sealed at an angle.A thin seal line was visible and measured less than 6mm wide.The opening measured approximately 1- 1.5cm.Sterilization of the package was compromised.A review of the device history record found three non-conformances related to the reported failure mode.The three devices were reworked to meet specification.A review of complaint history records shows no other complaints associated with the complaint device lot.The returned device was found to have an incomplete seal.The pouch was not located properly in the sealer during the sealing operation, leading to a seal that "ran off" the end of the pouch.Process improvements have been identified, but had not been implemented at the time that this product was manufactured.Cook has concluded that a manufacturing deficiency contributed to this complaint.Per the quality engineering risk assessment, no further action is warranted.We 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: 9497240
• MDR Text Key: 175902919
• Report Number: 1820334-2019-03157
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)220708(10)9862513
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: G48294
• Device Catalogue Number: NGE-017115
• Device Lot Number: 9862513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1