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

Model Number	WB991036
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Energy Output Problem (1431); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Bowel Burn (1756); Bowel Perforation (2668); Gastrointestinal Hemorrhage (4476)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, but not received.Follow up attempts remain ongoing.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during a gastrointestinal endoscopy procedure, multiple colon polyps were discovered.Due to the lack of audible prompts for electrocoagulation and electrosection, unstable output power of the electrosurgical generator, and inaccurate displays of data, issues arose with the polyp removal procedure which led to perforation, electrical injury (interpreted as burn) and bleeding in the patient's gastrointestinal tract.The operating surgeon immediately irrigated the wound, located the bleeding site, closed the wound with titanium clips, and transferred the patient to the department of surgery for enterorrhaphy.There was a surgical delay of approximately 4-5 hours.It was reported that the patient recovered and was discharged from the hospital.The customer later stated that the perforation occurred due to electrode failure.This is report 1 of 2.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: d9, h6, h11.Based on the results of the investigation, and since the device was not returned for evaluation, the event was not confirmed, and the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Common Device Name: ELECTROSURGICAL SYSTEM 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 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25185176
• Report Number: 3003724334-2026-00263
• Device Sequence Number: 13437463
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2017
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROSURGICAL SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male