MAUDE Adverse Event Report: GYRUS ACMI L.P. DPIG HC 7X26; STENT, URETERAL

Model Number	5607026
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported that during receipt inspection of the double pigtail ureteral stent, ¿the outer packaging was bent, and the seal was broken¿.The sterility of the device has been compromised.No death or injury and no impact to patient or other has been reported.Two devices with the same issue were reported by the customer.This report is for device 1 of 2.The second device is being reported on medwatch patient identifier (b)(6).
Additional Manufacturer Narrative
The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus for inspection, and the customer's complaint was unable to be confirmed.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 was unable to be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: DPIG HC 7X26
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16896077
• Report Number: 3005975494-2023-00088
• Device Sequence Number: 6312103
• Product Code: FAD
• UDI-Device Identifier: 00821925004078
• UDI-Public: 00821925004078
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2024

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: 5607026
• Device Lot Number: MQNM050
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 07/27/2023; 06/20/2024
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/18/2023; 08/03/2023; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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