MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR ESG-410; WA91327U

Model Number	WA91327U
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has been reported as an asset return.The product analysis found that the device has switch not activating, error 0432 on power test, old software, energy failed self-check.Dhr/shr review is not required.A labelling review is not required.A risk review was not performed for a26 due to no user allegation.A historical review of the last 12 months of complaints was not performed for a26 due to no user allegation.A capa history review was not performed for a26 due to no user allegation.The complaint could not be confirmed, this device has been reported as an asset return.The failure mode was found with "switch not activating, error 0432 on power test, old software, energy failed self-check".The most probable cause of the complaint is d15 - cause not established the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.No further escalation is required.
Event or Problem Description
It was observed that during the device evaluation, the generator exhibited the high voltage power supply board had blown capacitor.After replacing the high voltage power supply board and fuses the unit failed self-test with an error 0432.There was no patient involvement.

• Brand Name: ELECTROSURGICAL GENERATOR ESG-410
• Common Device Name: WA91327U
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22023844
• Report Number: 3003724334-2025-00210
• Device Sequence Number: 9164165
• Product Code: GEI
• UDI-Device Identifier: 04042761087698
• UDI-Public: 04042761087698
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: WA91327U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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