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

Model Number WB91051W

Device Problems Electrical /Electronic Property Problem (1198); Defective Component (2292)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

During the repair inspection, the reported e210 error was confirmed which was due to a defective motherboard.Upon replacing the motherboard, additional issue was identified, the device displayed error message e433, which was traced back to a defective power supply (hvps) board.The inspection also noted non-reportable events such as - heavy corrosion on the contact surfaces of the ribbon cable which connects the display and the motherboard.Cracks on the docking connector and cracks and chipping (at the fixing lugs) on the front panel.The legal manufacturer (oste) performed a review of the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The reportable error, e433, is a known issue.The e433 error will occur if the effective value of the output signal falls below the specific limit.As a safety precaution, the device restarts.If the cause of the error persists, unlimited permanent restarts may follow, then the device is no longer operational.Based on the device evaluation, the cause of the e433 error was isolated to a defective hvps board.Error message e210 occurs if signal channel (ch) i has an incorrect (unexpected) state at the time of the check.For safety reasons, the esg-400 then performs a restart.Based on the device evaluation results, the e210 error was traced to a defective motherboard.In general, the customer is required to check the function of all devices used prior to a procedure.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states a suitable replacement device must be provided during an application.Olympus will continue to monitor complaints for this device.

Event Description

Olympus (omsi) was informed by the biomedical engineer at the user facility that the high frequency electro-surgical generator has a reported ¿error e210 pop up on screen intermittently¿ during preparation for use.No death or injury and no impact to patient or other has been reported to olympus.The device was returned to the olympus repair center.The reported e210 error was confirmed and due to a defective motherboard.However, upon replacing the defecting motherboard, an e433 error occurred and was isolated to a defective power supply board.This report is being submitted to capture the error e433 malfunction.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16191960
• MDR Text Key: 307579900
• Report Number: 9610773-2023-00248
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/18/2023

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: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• 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