MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH 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

E2 populated in error.The device was returned as part of the asset return process.The error 433 could not be reproduced, however, the generator board and the high voltage power supply (hpvs) were damaged and needs to be replaced.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The hf unit ¿esg-400¿ was returned as part of the asset return process.During routine inspection of the device by olympus, an error 433 was detected in the error log.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Event Description

The error was observed when connecting the device, not during a procedure.The device was replaced with another similar device.

Manufacturer Narrative

Updated fields: b5, h4, h6, h10.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information received from the customer.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 could not be determined as the reported error was not reproduced.Although it was not duplicated, the error was found in the logs, so it can be assumed that the error was triggered temporarily.Although the service department believed the generator board or high voltage power supply (hvps) to be the cause it is unlikely because the error would then be permanent.As the error was temporary, possible causes include; interference of the esg-400 generator due to scattered electromagnetic interfering fields (temporary fault), the operator activates the footswitch during generator booting (temporary fault caused by user action), a defective footswitch due to short circuit in the plug (temporary fault), a defective footswitch due to defective reed contact (temporary fault), a faulty cable connection between hvps board and generator board (temporary or permanent fault), and/or a faulty cable connection for the output signal between generator board and relay board (temporary or permanent fault).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; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17650396
• MDR Text Key: 322280574
• Report Number: 9610773-2023-02393
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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