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

Model Number	WA91307C
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during device evaluation, the generator had a bad flexray field programmable gate array board which caused the error 1010.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction is being made to previously submitted g3 - date received by manufacturer which was not late.The correct date was [sep/09/2024].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 suggested event was confirmed by olympus.During the inspection of the device, it was identified the printed circuit/flexray board as the cause of the reported issue.Additionally, the investigation refers to the service manual for the following potential service actions: check the connection of pcba flexray to the pcba control.Replace the pcba flexray.Check the connection of pcba surgisaber and pcba control to the pcba wiring.Replace the pcba surgisaber.Replace the pcba control and / or the pcba wiring.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: ELECTROSURGICAL GENERATOR
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19485182
• Report Number: 3003724334-2024-00169
• Device Sequence Number: 12743721
• Product Code: GEI
• UDI-Device Identifier: 04042761086349
• UDI-Public: 04042761086349
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203277
• 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): 10/04/2024

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: Other
• Device Model Number: WA91307C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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