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

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	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device inspection, the generator foot switch of electrosurgical generator had an error code of e433.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).The initial mdr was inadvertently submitted, as a reportable malfunction.This supplemental report is to inform, that there was no device returned for inspection.And there was no reportable malfunction related to the subject device captured in this complaint.

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: GENERATOR FOOT SWITCH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19152341
• Report Number: 9610773-2024-01064
• Device Sequence Number: 8434451
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: Other
• Device Model Number: WB50402W
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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