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 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

During troubleshoot with the olympus technical assistance center (tac), the customer disconnected the footswitch, reboot the system and then the e433 error went away.The customer then discovered the corresponding footswitch's cord was damaged.To date, the subject unit has not been returned.A review of the unit's history shows the unit was purchased on (b)(6) 2019, with no repair records.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 an unspecified event, the electro-surgical generator was getting an e433 malfunction of footswitch error.No patient involvement was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer 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.According to the reported information, when the connected foot switch was replaced, the error e433 was not displayed anymore.The cable of the affected foot switch was found to be damaged.Thus, error e433 can very likely be traced back to a defective foot switch.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: 11109260
• MDR Text Key: 263579933
• Report Number: 9610773-2021-00039
• 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: 03/15/2021

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: Other
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: B006531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1