MAUDE Adverse Event Report: GYRUS ACMI, INC. FLEX-CATCH 4 WIRE NITINOL BASKET; EXTRACTOR, STONE REMOVAL

Model Number	NT4F19115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the wire of the subject device was broken.The issue was observed during retrograde intrarenal surgery (rirs).The procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.The device was inspected and the basket wire was found to be damaged/broken with the ball tip bent from the distal end side.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the malfunction was caused by component failure.The reported event is described in "warnings and cautions" and "operational instructions": warnings and cautions ¿ kinks and deformation of the sheath can potentially affect the mechanical performance of the device.Do not directly fire any lithotripsy system (pneumatic, ultrasonic, laser or other) upon the device as significant damage and patient injury may occur.Operational instructions removal 1) caution: do not apply excessive force on the device.Once the object is captured inside the device carefully remove the scope and stone dislodger simultaneously from the urinary tract.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Common Device Name: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22871704
• Report Number: 3011050570-2025-00942
• Device Sequence Number: 14874781
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: 00821925041349
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT-FGO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: NT4F19115
• Device Lot Number: 92402916
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown