MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-150"

Model Number	WA90150J
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1/initial reporter establishment name: (b)(6) hospital.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
It was reported during a therapeutic gastric endoscopic submucosal dissection (esd) procedure in which an electrosurgical knife was used in combination with an electrosurgical generator, a perforation occurred just before the procedure was completed.The perforation occurred in the stomach with a size of 2 or 3 centimeters.The lesion was resected and transferred directly to a surgical operation.The patient was reported to be hospitalized but in good health with no abnormalities.The patient was scheduled to be discharged.It was noted that the physician's opinion regarding the device and the perforation was "the output with the needle knife, was it a little high that the effect was 3".There were no further reports of patient harm.Additional information was obtained through a meeting with the physician.The customer indicated there was no malfunction or concerns with the electrosurgical knife and no trouble, including behavior of the main body, with the electrosurgical generator.It was reported the patient had already been discharged from the hospital this is report 2 of 2.
Additional Manufacturer Narrative
Updated fields: d8, h2,h3, h4, h11.This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was not confirmed.A definitive root cause could not be identified.Based on the results of the investigation no nonconformances were found related to this complaint.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-150"
• Common Device Name: ELECTROSURGICAL GENERATOR
• 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: 24507844
• Report Number: 3003724334-2026-00123
• Device Sequence Number: 10115445
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• 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): 04/15/2026

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: WA90150J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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: KD-1L-1 ELECTROSURGICAL KNIFE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: Asian