MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "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 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The oem performed 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.As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The concerned device was not returned to the oem for evaluation; therefore, the root cause of the reported event cannot be conclusively determined.However, based on the service/repair evaluation the generator board was identified as the cause of the reported error.Additionally, a slight discoloration of the front panel was noticed.The generator board was replaced; passed all functional tests and was returned to the customer.A review of the repair history of the device shows no previous repair records; purchased on september 2, 2020.The reported 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 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.

Event Description

The service center was informed by the biomed at the user facility that the high frequency electro-surgical generator unit keeps shutting off / error message during a procedure.The generator was returned for service.Upon inspection and testing, the reported issue was confirmed as the device displays an e433 error code when powering on.No patient injury or harm was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the user facility and to update the following sections: a3, a6, b5, g3, g6, h2 and h10.

Event Description

The certified surgical technologist further reported that the generator unit kept "shutting off / error message" near the end of a transurethral resection of the prostate procedure.There was no continuous restarting of the device when powered on.The device was inspected prior to use; no anomalies were observed.The device was replaced and the intended procedure was completed.No patient harm or adverse outcome to he procedure was reported.

• 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: 12338427
• MDR Text Key: 267306781
• Report Number: 9610773-2021-00230
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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
• Device Lot Number: B007507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1