MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL GENERATOR 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 01/31/2023

Event Type  malfunction  

Event Description

Olympus (oekg) was informed via service request that the customer high frequency electro-surgical generator ¿turned off without turning back on¿ during use in the operating room.The customer reported event was found at an unspecified event.The generator was returned to olympus for evaluation.Upon inspecting and testing, it was identified the unit displayed error e433.The issue was isolated to a defective power supply (hvps) board.No death or injury and no impact to patient or other has been reported to olympus.This report is being submitted to capture the error e433 malfunction.

Manufacturer Narrative

The olympus evaluation identified the unit displayed error e433.The issue was isolated to a defective power supply (hvps) board.It is recommended the software be updated to the latest version.No visible damage was observed.The cause of the defective hvps board is unknown, however, the investigation is still ongoing.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental is being submitted to provide additional details of the event and results of the investigation.A review of the device history records (dhr) was performed for the affected serial number without.Based on the physical inspection of the device, the cause was isolated to a defective high voltage power supply board.The cause of the defective hvps board is unknown.In general, the customer is required to check the function of all devices used prior to a procedure.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states a suitable replacement device must be provided during an application.Olympus will continue to monitor complaints for this device.

Event Description

The customer further reported event occurred on january 31, 2023.The electro-surgical generator went off several times during operation and it was necessary to replace generator with another similar device to complete the intended surgical procedure.No death or injury was reported, and no further information was provided.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16311546
• MDR Text Key: 309655103
• Report Number: 9610773-2023-00431
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1