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

Model Number	WA90300W
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported when the argon plasma coagulation unit was connected to the electrosurgical generator, an e679 error code was displayed and the "green tank" icon expected to be on the display was not present.The issue occurred during a therapeutic colonoscopy and the procedure was prolonged greater than 30 minutes.There were no reports of patient harm.This report is related to the following linked patient identifier: (b)(6).

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-300", WITH FOOT SWITCH
• Common Device Name: WA90300W
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 20885765
• Report Number: 2429304-2024-01028
• Device Sequence Number: 13022530
• Product Code: GEI
• UDI-Device Identifier: 04042761085977
• UDI-Public: 04042761085977
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/09/2024
• Report Date (Section F): 12/09/2024

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: WA90300W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/11/2024
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• 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: ARGON PLASMA COAGULATION UNIT WA90004W
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/09/2024