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

Model Number	WA90150W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the electrosurgical generator esg-150 had the foot pedal not make contact with the generator.The issue was found during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned and the evaluation found that the motherboard had insufficient contact with the board and the electronic component.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported faulty foot switch activation issue was determined to be due to a faulty mother board/circuit board.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3003724334.

• Brand Name: ELEKTROCHIRURGIEGERÄT "ESG-150"
• Common Device Name: DEVICE ELECTROSURGICAL GENERATOR ESG-150
• 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: 18754339
• Report Number: 9610773-2024-00497
• Device Sequence Number: 3740695
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K182587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA90150W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 07/12/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/12/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Patient Sex: Unknown