MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY OLYMPUS ESG-100, 220...240 V~,

Model Number	WB991036
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the olympus esg-100, displayed error code 234.The issue occurred during reprocessing.There was no patient involvement.
Additional Manufacturer Narrative
E1 - initial reporter establishment: (b)(6), e1 - address: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8, e4, h4, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.The device was returned to olympus for inspection, and the reported failure was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the error 234 was due to a component failure of the communication board.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No new additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the previously submitted supplemental report.Corrected fields: g3 - date received by mfg.Is 10/30/20225, and not 10/13/2025.
Event or Problem Description
No new additional information received from the customer.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Common Device Name: OLYMPUS ESG-100
• 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: 23337039
• Report Number: 3003724334-2025-00521
• Device Sequence Number: 20785592
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

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: WB991036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 11/04/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2015
• 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