MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH PRESSURE REDUCER, WITH CONNECTOR ACC. TO CGA NO. 580, FOR ARGON PLASMA; WA94043A

Model Number	WA94043A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While evaluating a returned olympus pressure reducer, the housing of the unit was leaking near the tank connection.There was no patient involvement during this event.
Additional Manufacturer Narrative
D1 model description was too long for field character limit: pressure reducer, with connector acc.To cga no.580, for argon plasma coagulation the evaluating of the event is ongoing.Should additional information be received, a supplemental report will be provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additional information: h3, h6, h11.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: PRESSURE REDUCER, WITH CONNECTOR ACC. TO CGA NO. 580, FOR ARGON PLASMA
• Common Device Name: WA94043A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20734195
• Report Number: 9610773-2024-02705
• Device Sequence Number: 15546130
• Product Code: GEI
• UDI-Device Identifier: 04042761083591
• UDI-Public: 04042761083591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: Other
• Device Model Number: WA94043A
• Device Lot Number: 07/18/0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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