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

Model Number WB91051W

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.The customer¿s allegation (e433 error code) was not reproduced during device evaluation but found in the error logs, therefore, it is likely this error was temporary.The e433 error is activated by the device¿s safety system, which triggers a restart of the device.If the error cause persists, an unlimited number of periodic restarts can be triggered.Possible causes of the temporary e433 error could be a result of the following: interference of the esg-400 generator due to scattered electromagnetic interfering fields, the operator activates the footswitch during generator booting, a defective footswitch, a faulty cable connection between high voltage power supply (hvps) board and generator board, or a faulty cable connection for the output signal between generator board and relay board.A user error cannot be completely excluded for this error.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been 4 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported that the high frequency electrosurgical generator unit had an error code e433 displayed.The event occurred during preparation for use.There was no patient harm associated with the event.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17662735
• MDR Text Key: 322415525
• Report Number: 9610773-2023-02410
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• 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