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

Catalog Number NGE-022115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Customer name and address- postal code: (b)(6).Pma/510(k) number: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, when testing the device prior to use for a transurethral lithotripsy, the basket of an ngage nitinol stone extractor was able to be closed, but could not be opened.The device did not make patient contact.The procedure was completed with another device of the same type.The patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a ngage nitinol stone extractor.The basket of the device reportedly would not open before use during a tul procedure.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.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.The device was returned with the handle in the open position but the basket formation in the closed position.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 3.5 cm in length.The braiding on the basket sheath had a melted appearance and was partially separated 2mm from the support sheath.The functional test determined the handle does not actuate the basket formation.The handle was disassembled, and the basket formation could be manually actuated.The handle was rest, and the function test then noted the handle would actuate the basket formation, but it would not fully open.A review of the device history record (dhr) 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 related complaints from the lot 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 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.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.The returned device was found to have a basket that was closed and could not be opened.Damage to the basket sheath was noted, with it being partially separated near the yellow support sheath.The sheath damage was likely interfering with the free movement of the basket assembly inside the sheath.The device was disassembled and reassembled, with partial basket function restored, but the basket would not open fully.The cause for the basket sheath damage could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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: 11091154
• MDR Text Key: 224391819
• Report Number: 1820334-2020-02382
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482972
• UDI-Public: (01)10827002482972(17)230914(10)13426447
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: NGE-022115
• Device Lot Number: 13426447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1