MAUDE Adverse Event Report: GYRUS ACMI L.P. BIOPSY PORT SEAL (6-PER); ENDOSCOPIC BIOPSY VALVE, STERILE

Model Number	AUR-BP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the evaluation is pending.The investigation is ongoing, and 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 olympus sales representative reported (on behalf of the customer) that there was a leak on the biopsy port seal (6-per).The issue occurred during the therapeutic procedure (ureteroscopy), there was no delay, and the procedure was completed with a similar device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned for inspection, and the customer's reportable malfunction was not 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 device passed all of the leak tests.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 3011050570.

• Brand Name: BIOPSY PORT SEAL (6-PER)
• Common Device Name: ENDOSCOPIC BIOPSY VALVE, STERILE
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; suite 102; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; suite 102; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16378078
• Report Number: 3003696010-2023-00002
• Device Sequence Number: 14892845
• Product Code: FGB
• UDI-Device Identifier: 00821925038837
• UDI-Public: 00821925038837
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K012929
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2024

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: AUR-BP
• Device Lot Number: MQJJ770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 06/19/2024
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 06/10/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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