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

Model Number WB91051W

Device Problem Activation Problem (4042)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.

Event Description

It was reported to olympus that the error 433 was generated and the device continuously restarted.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: d8, d9, g3, g6, h2, h3, h4, h6 and h10.The device was returned to the olympus service center.The evaluation confirmed the reported error, e433, as the device kept rebooting and prompted ¿error e433¿ upon start-up.Troubleshooting was performed and problem has been isolated to the generator pc board.The device was repaired and returned to the customer.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.Based on the evaluation findings, the reported e433 error was confirmed to be due to a faulty generator board.Error e433 is triggered by the security system of the esg-400.It results in a restart of the generator.If the cause of the error remains, there can be unlimited periodic restarts.Possible causes: 1.The user presses the foot switch while the generator is booting (temporary error caused by user action).2.Defective foot switch (temporary error).3.Defective foot switch (temporary error, defective reed contact).4.Defective cable connection between hvps board and generator board (temporary or permanent fault).5.Defective hvps board (permanent error).6.Defective generator board (permanent error).7.Defective motherboard (adc, permanent error).A more detailed examination of generator boards with the error e433 revealed a destroyed transformer as the cause.An improved generator board was introduced into production from mid-july 2020.The scratches on the external housing are signs of use that can occur when handling the generator.Olympus will continue to monitor complaints for this device.In general, 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.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: HF UNIT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11325504
• MDR Text Key: 244072941
• Report Number: 9610773-2021-00077
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: B003940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1