MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY OLYMPUS ESG-100, 100...120 V~,; Electrosurgical, cutting & coagulation & accessories

Model Number	WB991046
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection that generator had an e216 and e234 error.There were no reports of patient involvement.
Additional Manufacturer Narrative
The product was returned for investigation.Based on the results of the investigation and the information provided: error e216 is an internal abnormality and occurs when output level could not recognize and setting value was return to default when monopolar forcedcoag1 or forcedcoag2 is selected.It likely occurs by electrical signal communication abnormality or some electrical abnormality in the electronic board.Error e234 is an internal abnormality, and it occurs when communication abnormality between the internal electronic boards.It likely occurs by electrical abnormality or some electrical abnormality in the electrosurgical generator.However, the root cause of insulation beak failure could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Common Device Name: Electrosurgical, cutting & coagulation & accessories
• 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: 23895615
• Report Number: 3003724334-2025-00652
• Device Sequence Number: 4619836
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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: Health Professional
• Device Model Number: WB991046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/26/2025
• 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