MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELEKTROCHIRURGIEGERÄT "ESG-150"; WA90150W

Model Number	WA90150W
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a colonoscopy, the physician positioned the snare around a polyp and attempted activation using the yellow pedal on the generator footswitch.No energy output was delivered, and the snare reverted to a cold state.As a result, the tissue was transected mechanically rather than by electrocautery, leading to bleeding.The physician controlled the bleeding using a clip, and the procedure was completed.The patient was admitted for observation and discharged the next day.

• Brand Name: ELEKTROCHIRURGIEGERÄT "ESG-150"
• Common Device Name: WA90150W
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• MDR Report Key: 23555009
• Report Number: 2429304-2025-00294
• Device Sequence Number: 18655182
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/14/2025
• Report Date (Section F): 11/14/2025

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: WA90150W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/17/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FOOT SWITCH; SNARE (LOT # 45V)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/14/2025