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

Model Number	NT4F19115
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during stone removal from the ureter, the flex-catch 4 wire nitinol basket remained blocked with stone inside.The physician proceeded to remove the stone via laser procedure.The procedure was completed with a few minutes of delay deemed not clinically relevant and with no harm to the patient or impact to the procedure.Additional information has been requested regarding the event; however, no information has been received at this time.
Additional Manufacturer Narrative
The suspect device was disposed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Despite good faith attempts the user did not respond to request for futher information.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation and because the subject device was not returned, the reported event could not be confirmed and a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Common Device Name: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18055329
• Report Number: 3003790304-2023-00420
• Device Sequence Number: 20352291
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: 00821925041349
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 92202137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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