MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH FOOT SWITCH, DOUBLE, FOR, ESG-400; WB50402W

Model Number	WB50402W
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the foot switch of the electrosurgical generator had an error code e433.There were no reports of patient involvement.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.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 investigation.The customer's allegation was confirmed.Based on the results of the investigation, it is likely that the following led to the malfunction: damage to the foot switch.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.This report is related to mfr 3003724334 - 2024 - 00388 (1/2).

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: WB50402W
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20453424
• Report Number: 9610773-2024-02518
• Device Sequence Number: 7203740
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: Other
• Device Model Number: WB50402W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WB91051W - HF GENERATOR
• Patient Sex: Unknown