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 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device is pending return for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that an hf unit "esg-400" had an error code e433 displayed.There was no patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the suggested event could not be concluded, although it can be presumed that the defect was caused due to the generator board as described below.Since strong voltage peaks may occur at the output transformer of the generator board, which can destroy the transformer, there is a chain of protective diodes (tvs diodes) on the relay board in front of the relay contacts, which are intended to suppress these voltage peaks.They can be configured for three different voltage ranges.When the device is started, this diode chain is tested for function by current flow if the voltage is exceeded or fallen below, which indicates a high impedance (open) or short circuit (short).The error message e433 can therefore only occur when the device is started.From a technical point of view, the error message e433 cannot occur during operation.However, the possible cause of the error message arises during operation.The error message e433 occurs if, when starting the device, the effective value of the output signal set for testing falls below the intended limit of 130v, which normally indicates a low-resistance diode chain.For security reasons, the esg-400 will then be restarted.If the cause of the error remains, unlimited permanent restarts can result.The device is then no longer ready for use.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17672570
• MDR Text Key: 322533796
• Report Number: 9610773-2023-02422
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2011
• 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