MAUDE Adverse Event Report: GYRUS ACMI, INC. LITHOSTENT 7.0X28CM; STENT, URETERAL

Model Number	5637028
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the lithostent had a crushed package on transport.The sterility was compromised.The issue was found during receipt inspection.There was no patient or procedure involvement.
Additional Manufacturer Narrative
Correction: e2 and e3 were inadvertently omitted from the initial report.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the root cause of the event was unable to be identified.The reported complaint was confirmed.The package being crushed likely happened during transport.Olympus will continue to monitor field performance for this device.

• Brand Name: LITHOSTENT 7.0X28CM
• Common Device Name: STENT, URETERAL
• 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: 18423320
• Report Number: 3011050570-2024-00003
• Device Sequence Number: 7771423
• Product Code: FAD
• UDI-Device Identifier: 00821925005129
• UDI-Public: 00821925005129
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960148
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: 5637028
• Device Lot Number: MQKZ990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/17/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 01/01/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown