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

Catalog Number NGE-017115

Device Problems Difficult to Advance (2920); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Event Description

As reported, the basket of an ngage nitinol stone extractor would not completely close, preventing the device from going through the scope.The device was tested prior to use.A laser was used.The unspecified procedure was completed with an unspecified competitor's device.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510k #¿ exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) hospital reported on 18may2023 that there were three incidents with a ngage nitinol stone extractor (rpn: nge-017115, lot number: 15213897), documented in manufacturer reference #s 1820334-2023-00725, 1820334-2023-00726, and 1820334-2023-00727.This report addresses one of the events.No patient specific information is available.The basket would not completely close, preventing the device from going through the scope and capturing stones.The device was tested prior to use.A laser was used during the procedure.The procedure was completed with an unspecified competitor's device.No adverse effects were reported for this incidence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and functional test of the related complaint devices, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, three ngage nitinol stone extractors were returned for related complaint #1820334-2023-00725.Two of the extractors were in unopened packaging and one was in opened packaging, all labelled with lot 15213897.All three devices opened and closed fully when tested.There was no visible damage to the unopened products.The opened product had a bent support sheath and a slight kink in the basket sheath (likely due to how it was shipped as the device was returned loaded in the packaging tray incorrectly), however the basket was still functional.The reported failure mode was not able to be repeated.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 15213897 records no relevant non-conformances.A search of the complaint database found only the three complaints that were reported by this customer for the lot.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.Cook also reviewed product labeling.The product ifu, t_shef_rev1; the ifu did not provide any information related to the reported issue.The evidence from the complaint file, device history record, complaint history, quality control documents, and evaluation of related complaint devices indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Based on the information provided, inspection of the related complaint devices, and the results of the investigation, cook has concluded a cause for the complaint cannot be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17117989
• MDR Text Key: 317080316
• Report Number: 1820334-2023-00726
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260208(10)15213897
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NGE-017115
• Device Lot Number: 15213897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1