MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR "ESG-300", WITH FOOT SWITCH; WA90300W

Model Number	WA90300W
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Abdominal Pain (1685); Necrosis (1971); Perforation (2001)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the physician weighed on the pedal to activate the argon, the electrosurgical generator did not produce an electric beam during a therapeutic colonoscopy to treat the patient's caecal angiodysplasia using an axial argon probe.When doctor weighed on the pedal to activate the argon, the beam electric did not create itself, however, he saw the colon contract.After a few tests, the electric beam was finally created, and a superficial coagulation was observed.Every time the argon pedal was used the patient reacted to the energy like an electric shock.Sometime after the procedure, the patient went back to the emergency room due to abdominal pain and was then sent back to the operating room where a 3cm necrosis was found which was not present during the initial endoscopic vision procedure.Ileo-caecal resection was done to treat the perforation.
Additional Manufacturer Narrative
The investigation is ongoing.This report is related to the following linked patient identifier: (b)(6).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 legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure could not be confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: no problem detected either it was not confirmed that there was a problem with the device, or it was confirmed that there was no problem with the device.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct previously submitted emdr.B1 should not be marked as a product problem.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-300", WITH FOOT SWITCH
• Common Device Name: WA90300W
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20789656
• Report Number: 9610773-2024-33570
• Device Sequence Number: 12757519
• Product Code: GEI
• UDI-Device Identifier: 04042761085977
• UDI-Public: 04042761085977
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180200
• 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,Followup
• Report Date (Section B): 04/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA90300W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 04/16/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/27/2025; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female