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

Catalog Number NGE-017115

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

G4: pma/510k #¿ exempt.H3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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

As reported, a basket wire of an ngage nitinol stone extractor was discovered broken when attempting to remove a stone and the stone could not be removed.There were no adverse effects to the patient reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Investigation ¿ evaluation as reported, the basket wire of an ngage nitinol stone extractor was found to be broken upon removal from the packaging and was not used on the patient.A new extractor was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.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 of the returned device, were conducted during the investigation.One device was returned in a package without label.Upon inspection 3 broken/cut wires were sticking out of the distal end of the basket sheath.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 dhr for the reported complaint lot and recorded no relevant nonconformances related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, t_shef_rev1, did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause of this event could not be determined.The basket assembly is manufactured by a supplier and a nonconformance investigation has been opened to investigate this issue.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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 26jan2024.Correction: d10: concomitant products correction: h6: annex e, annex f 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 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.

Event Description

Additional information received 26jan2024: the wire was found to be broken upon removal from the packaging and was not used on the patient.A new 'ngage nitinol stone extractor' was used to complete the procedure.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• 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: 18104142
• MDR Text Key: 329132676
• Report Number: 1820334-2023-01535
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)260425(10)15406855
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 15406855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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
• Treatment: OLYMPUS SCOPE.