MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY HF UNIT "ESG-400"; ELECTROSURGICAL GENERATOR ESG-400

Model Number WB91051W

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the electrosurgical generator exhibited a defective generator board that caused an error message and reboot.There were no reports of patient involvement.

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 event was unable to be identified.The e433 error was likely cause by a faulty generator board.The damaged front panel cover and the dented top cover were likely due to improper handling by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18833194
• MDR Text Key: 337768742
• Report Number: 3003724334-2024-00025
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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
• Device Operator: Other
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1