MAUDE Adverse Event Report: GYRUS ACMI, INC. ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE

Model Number NT4W18115

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

A user facility reported to olympus upon opening the box and checking the actual product, the basket wire was cute.The therapeutic transurethral lithotripsy procedure was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

The subject device is expected to be returned to olympus for further evaluation and testing.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was manufactured in march 2023.As the device was not returned, a physical device inspection could not be performed.As a result, the complaint could not be confirmed, and potential causes could not be determined the suggested event is detectable and preventable by handling the scope in accordance with the following section of the instructions for use: "prior to use, inspect the device for any visible damage such as kinks or broken stone dislodger wires; do not use the product should the product or its container be received damaged.Contact olympus for authorization to return the product for reinspection and/or replacement." olympus will continue to monitor field performance for this device.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL DEVICE
• 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: 17480463
• MDR Text Key: 321317921
• Report Number: 3011050570-2023-00111
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 00821925027725
• UDI-Public: 00821925027725
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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
• Device Operator: Health Professional
• Device Model Number: NT4W18115
• Device Lot Number: KR276868
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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