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

Model Number AUR-BP

Device Problem Leak/Splash (1354)

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

Event Date 01/17/2023

Event Type  malfunction  

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 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.

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.

• Brand Name: BIOPSY PORT SEAL (6-PER)
• Type of Device: ENDOSCOPIC BIOPSY VALVE, STERILE
• Manufacturer (Section D): GYRUS ACMI, INC.; one monarch drive; suite 102; littleton MA 01460
• Manufacturer (Section G): GYRUS ACMI, INC.; one monarch drive; suite 102; littleton MA 01460
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16378078
• MDR Text Key: 309562970
• Report Number: 3003696010-2023-00002
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925038837
• UDI-Public: 00821925038837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2023

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: 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
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1