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

Model Number	WB50403W
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the high frequency electrosurgical generator unit had an error code e433 displayed.The event occurred during preparation for use.There was no patient harm associated with the event.For the esg-400 device, please see patient identifier (b)(6).This file captures the footswitch used in conjunction with the esg-400.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction for the footswitch and was submitted in error.The initial medwatch reported the high frequency electrosurgical generator unit had an error code e433 displayed; however; this event has already been reported on medwatch 9610773-2023-02410 (patient identifier (b)(6)).Refer to this file for supplemental information related to this event.
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 9610773.

• Brand Name: FOOT SWITCH, SINGLE, FOR, ESG-400
• Common Device Name: ELECTROSURGICAL GENERATOR
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17695682
• Report Number: 3003724334-2023-00033
• Device Sequence Number: 2558867
• Product Code: GEI
• UDI-Device Identifier: 04042761076814
• UDI-Public: 04042761076814
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024

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: WB50403W
• Device Lot Number: 1934-2608
• Was Device Available for Evaluation?: No
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 06/21/2024
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/25/2023; 06/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400
• Patient Sex: Unknown