MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY OLYMPUS ESG-100, 100...120 V~,; WB991046

Model Number	WB991046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a therapeutic colonoscopy, the physician was performing a sigmoid polypectomy when the yellow foot pedal of the esg-100 was inadvertently pressed.The physician reported that this action caused the generator to switch from coag to cut mode, resulting in an unintended cut and a perforation of the sigmoid colon at approximately 20 cm.The perforation was identified visually during the procedure.The size and depth of the injury were not recorded.Six hemostasis clips were placed to stabilize the perforation site, and the patient was transferred to a hospital for further treatment.The patient underwent a sigmoid colon resection with ostomy.No icu admission was required, and no post-operative complications such as peritonitis or sepsis were reported.The patient was discharged home.An ostomy reversal procedure is scheduled for a later date.There is no alleged or confirmed device malfunction.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Common Device Name: WB991046
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• MDR Report Key: 22742225
• Report Number: 2429304-2025-00220
• Device Sequence Number: 15534322
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2025
• Report Date (Section F): 08/07/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2025
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 07/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• 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: PCF-HQ190L; SD-400U-10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/07/2025