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

Model Number WB91051W

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center with (1) power cable.The evaluation was performed and was unable to confirm the reported ¿will not fire when stepped on the peddle just made a beeping sound¿ as an error e433 occurred as a continuous rebooting cycle when the device was powered.The generator board was found defective.Additionally, there were minor scratches on top cover.Minor scratches and dings on front panel.The device was repaired to standard specifications and returned to the customer.A review of the device's repair history shows the device was sent in previously on january 3, 2020 for an output issue but the problem was not duplicated.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

During preparation for use of an unspecified therapeutic urology procedure, the high frequency electro-surgical generator unit would not fire and when stepping on the foot switch, the unit made an audio/beeping sound.There was no delay and the intended procedure was completed.No other devices were replaced during the procedure.No patient injury or harm was reported.

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 cause for the reported error e433 is very likely a defective generator board.An improved generator board was introduced in the manufacturing process in the middle of 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: 11138766
• MDR Text Key: 266676716
• Report Number: 9610773-2021-00042
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: B006172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1