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 Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
During a therapeutic polypectomy procedure using the generator, there was initially no output observed, followed by a sudden return of output accompanied by an increase in bleeding that was greater than expected.Hemostasis was achieved through the application of a clip.The procedure was completed using the same device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8 - was device serviced by third party?, d9 - date returned to mfg, and h3 - device evaluated by mfg? 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 for inspection, and the reported failure was not confirmed.Based on the results of the investigation, and since the malfunction was not confirmed during evaluation, the definite root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information that was inadvertently omitted from the initial report.Updated information: b5 and d10.The concomitant device list has been updated to include the foot switch, as it was involved in the activation attempt at the time of the 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
It was reported that during the therapeutic polypectomy procedure, the physician pressed the foot switch on the generator, but there was no activation.The device subsequently produced output.

• 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: 22212192
• Report Number: 3003724334-2025-00264
• Device Sequence Number: 18182158
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2025

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: WB991046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/25/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/07/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FOOT SWITCH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown