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	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not sent to olympus.A review of the device history record found no deviations that could have caused or contributed to the broken device.The device shipped according to specifications.As part of the in-process testing, the minimum tensile strength of the basket and the connection between the basket and the tensile wire is tested to 100%.Based on the results of the legal manufacturer's investigation, without physical device evaluation, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
A query of the manufacturer and user facility device experience (maude) database found a voluntary report that states the subject device broke upon normal ureteral stone retrieval.According to the report, all equipment pieces were intact and no harm was done to the patient.Because the voluntary report does not include contact information for the submitter, additional information cannot be requested.

• 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: 15801180
• Report Number: 3003790304-2022-00296
• Device Sequence Number: 16896583
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: 00821925041349
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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: 92100558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown