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.
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 final investigation.Updated field: h4.The device was not returned to olympus for inspection; however, the technical assistance center provided remote troubleshooting, and the investigation was completed based on available information.The event can be prevented by following the instructions for use, which state: proper confirmation of generator settings and understanding of footswitch functionality is required before and during each use.Failure to adhere to these guidelines may result in unintended mode activation and compromise patient safety.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The most probable cause is failure to follow instructions, as the issue was traced to the user not adhering to the manufacturer's instructions for use.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• 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
• 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: 22742209
• Report Number: 3003724334-2025-00363
• Device Sequence Number: 12858443
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2018
• 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: PCF-HQ190L.; SD-400U-10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female