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

Model Number WB91051W

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

The unit was not returned for evaluation.However, the investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The biomedical engineer at the user facility reported that during an unspecified therapeutic procedure the user encountered an e433 error on this high frequency electro-surgical generator.The error came up twice within 15 seconds.The user used another unit to proceed and complete the procedure.No patient injury, death or infection was reported.The biomedical engineer was unable to duplicate the issue.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the reporter, the legal manufacturer and to update the following sections: g3, g6, h2, h4, h6 and h10.The biomedical engineering supervisor at the user facility further reported that the reported e433 error was first noticed before procedure.This device will not be returned to olympus as the error code has not reoccurred.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 e433 error is activated by the device's safety system, which triggers a restart of the device.If the error cause persists, an unlimited number of periodic restarts can be triggered.The possible causes are as follows: 1 - the operator activates the footswitch during generator booting (temporary error caused by user action).2 - a defective footswitch (temporary error).3 - a defective footswitch (temporary error, defective reed contact).4 - a faulty cable connection between hvps board and generator board (temporary or permanent error).5 - a defective hvps board (permanent error).6 - a defective generator board (permanent error).7 - a defective motherboard (adc, permanent error).A deeper investigation of generator boards with error e433 found a destroyed transformer tr1 to be the cause.An improved generator board was introduced into production in mid-july 2020.Olympus will continue to monitor complaints for 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: 11271940
• MDR Text Key: 244084710
• Report Number: 9610773-2021-00065
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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: B000181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1