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

Model Number NT4F19115

Device Problem Break (1069)

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

Event Date 09/27/2021

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307986198
• Report Number: 3003790304-2022-00296
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: 00821925041349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1