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 Type  malfunction  

Manufacturer Narrative

The repair inspection identified the device malfunctioned with error code e433.The malfunction was isolated to a defective generator board.The inspection also observed scratches on the external housing chassis and a slight dent on the front panel, missing rubber foot and damaged connector.The investigation is in progress; therefore, the root cause cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

Olympus (obl) was informed that the asset high frequency electro-surgical generator was returned the olympus repair center for general maintenance.No defect or malfunction was associated with asset.However, during the repair inspection, error code e433 was identified and was isolated to a defective generator board.No death injury or infection and no impact to person or other was reported to olympus.This report is being submitted to capture the malfunction, e433 error code.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since strong voltage peaks may occur at the output transformer of the generator board, which can destroy the transformer, there is a chain of protection diodes (tvs diodes) on the relay board, which are supposed to suppress these voltage peaks.They can be configured for three different voltage ranges.When the esg-400 is started, this diode chain is checked for short circuit (short) or high impedance (open) under various conditions.The error message e433 occurs when the effective value of the output signal falls below the specified limit, which normally indicates a low-impedance diode chain.For safety reasons, the esg-400 will then be restarted.If the cause of the error remains, unlimited permanent restarts may be the result.Please note that the unit is then no longer ready for use.Kindly note that it is theoretically possible that when error message e433 occurs, error message e460 may also occur.However, the checks for the output of e433 are carried out before the checks for e460.It should be mentioned that a restart of the generator is the consequence in both cases.It is important to state that in the case of the occurrence of e433 no further check for e460 will be carried out.E433 therefore covers e460.The possible causes for the occurrence of error message e433 are: 1) malfunction of the esg-400 due to interspersed electromagnetic interference fields (temporary error).2) the user operates the footswitch while the generator is booting (temporary error caused by the user).3) defective foot switch (temporary error).It should be mentioned that this issue was addressed under capa 147p-017 which was implemented on 30 march 2015.4) defective foot switch (temporary error, defective reed contact).5) defective cable connection between the hvps board and generator board (temporary or permanent error).6) defective cable connection for the output signal between the generator board and relay board (temporary or permanent error).7) defective current transformer on the generator board (permanent error).8) defective impedance transformer on the generator board (permanent error).9) defective peak rectifier on the generator board (permanent error).10) insufficient output voltage due to poorly switching hf output stage on the generator board (permanent error).11) no or insufficient supply voltage from the hvps board (permanent error).12) defective motherboard (ntc1, permanent error).13) defective motherboard (adc, permanent error).14) defective tvs diodes on the relay board (permanent error).Kindly note that if the error message e433 occurs only sporadically (temporarily), then no further action is necessary.However, if error message e433 occurs frequently or even permanently, the esg-400 should be technically inspected.Based on experience, the generator board, the hvps board, the motherboard and finally the relay board should be tested in another esg-400 with regards to error message e433 and replaced if necessary.In general, in the case of permanent error patterns, it can be assumed that only one component is faulty.Kindly note that multiple failures are rare.However, in case of uncertainty, suspected components should be tested in a test unit.On 28 february 2020, a potential quality improvement was published in relation to error e433.A deeper investigation of generator boards with error e433 found a destroyed transformer "tr1" to be the cause.It is important to mention that from the beginning of july 2020, an improved generator board was introduced into production.The replacement of the generator board is only necessary if the old generator board is proven to be defective and causes a permanent error pattern.In the case of temporary error patterns or if the error message e433 cannot be reproduced at all, replacement of the generator board is not advisable, even as a precautionary measure.Also note that the new generator board has been introduced into production starting with the following serial numbers: (b)(6).Important information: the numeric part of the serial number is incremented.This means units with greater serial numbers were certainly equipped with the new generator board.Presently, an in-depth investigation of the hvps boards with error message e433 is being carried out by r&d.In this case, a fault on the part of the user cannot be completely ruled out.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, 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: 16115996
• MDR Text Key: 308639506
• Report Number: 9610773-2023-00117
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

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: 12/09/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 02/11/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• 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