MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH: BERLIN ELECTROSURGICAL GENERATOR "ESG-410"

Model Number	WA91307W
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the handpiece for cutting, and coagulation on his olympus electrosurgical generator was not functioning on the second monopolar port.There was no patient harm reported as a result of this event.
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The hand switch had stopped working after about 30 minutes of testing.No other faults were noted during the evaluation.No visible damage, no burned sections, and no signs of liquid inside the device.The faulty component will have to be replaced.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the mobile board was defective.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: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH: BERLIN; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH: BERLIN; rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17611523
• Report Number: 9610773-2023-02334
• Device Sequence Number: 12377033
• Product Code: GEI
• UDI-Device Identifier: 04042761086332
• UDI-Public: 04042761086332
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K203277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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: WA91307W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 07/01/2024
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/10/2023; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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