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

Model Number WB91051W

Device Problem Defective Component (2292)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The biomedical technician at the user facility reported that the high frequency electro-surgical generator kept displaying an e433 error and rebooting itself.There was no patient involvement as the event occurred during preparation for use.The unit was replaced and the intended procedure was completed.During troubleshoot via telephone, it was determined that the cause of the reported event was attributed to a faulty footswitch.

Manufacturer Narrative

The legal manufacturer performed the device history records for this 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 investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The error e433 is a known issue and is triggered by the safety system of the esg-400 and results in a restart of the generator.If the cause of the error remains, there may be an unlimited number of periodic restarts.Possible causes are: the user activates the foot switch while the generator is booting (temporary error caused by user action).Faulty foot switch (temporary error).Faulty foot switch (temporary error, faulty reed contact).Defective cable connection between hvps board and generator board (temporary or permanent error).Defective hvps board (permanent error).Defective generator board (permanent error).A deeper investigation of generator boards with error e433 found a destroyed transformer to be the cause.An improved generator board was introduced into production in mid-july 2020.As stated on the ifu (instruction for use) and as a preventive measure, the user manual indicates the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the ifu, a suitable replacement device must be provided during an application.The legal manufacturer will continue to monitor the field performance of this device.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: HF UNIT "ESG-400"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 12063567
• MDR Text Key: 268689038
• Report Number: 9610773-2021-00171
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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
• Device Lot Number: 14289W140018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1