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

Model Number	WB991036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a colonoscopy with polyp removal, a perforation occurred.This occurred during the use of the olympus generator and a non-olympus polypectomy snare.The customer believes the cause is not related to the integrity of the device, but to be 100% sure, they are sending the device for repair.Additional information indicated that the customer stated the event was caused by incorrect operation by the doctor and not a problem with the device.Additional information has been requested for clarification; however, it is not available at this time.
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: d8, d9, h2, h3.H4, h6 and h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus and the reported failure was not confirmed.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined, however; the most probable cause is identified as the cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
No additional information 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: 22889481
• Report Number: 3003724334-2025-00400
• Device Sequence Number: 18356150
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Report Date (Section B): 02/12/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2012
• 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: NON-OLYMPUS POLYPECTOMY SNARE.
• Patient Sex: Unknown