MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY OLYMPUS ESG-100, 220...240 V~,; WB991036

Model Number	WB991036
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedures, the settings of this electrosurgical generator were jumping across profiles.The user felt as if the "cut was too harsh" and "the coag was sharp".It was noted that there was an increase in "spentrotamy" bleeds.Additional information was received from the customer that the occurences of bleeding were detected after the procedure.There was significant bleeding in at least two patients necessitating blood transfusion and interventional radiology (ir) embolization in one.And a moderate bleeding in at least 1-2 patients requiring repeat endoscopy.An unspecified injection and a self-expandable metal stents (sems) were also used as part of medical intervention.The bleeding were stabilized following endoscopic therapy in all patients except in one patient who needed ir embolization.Further information was requested but not available at this time.There were no further reports of patient harm.This report is for patient #3 of 5, requiring ir embolization.
Additional Manufacturer Narrative
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 legal manufacturer's final investigation.Updated fields: h3, h4 and h6.The device was returned to olympus for inspection, and the reported failure was not confirmed.The output meets all specifications.Based on the results of the investigation, and since the device malfunction was not confirmed, the definitive root cause of the reported issue could not be determined.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Common Device Name: WB991036
• 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: 23930724
• Report Number: 3003724334-2025-00660
• Device Sequence Number: 8863105
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K073207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WB991036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FOOTSWITCH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown