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

Model Number WB91051W

Device Problem Defective Component (2292)

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

Event Date 07/19/2023

Event Type  Injury  

Event Description

The olympus representative reported on behalf of the customer that the loaner esg-400 was being used during a transurethral resection of a bladder tumor (turbt) procedure with an olympus bipolar resectoscope, and suddenly there was a loud bang that came from the unit, the display went blank, and the unit ceased to operate.Afterwards a rubbery, plastic smell was in the theatre but no smoke was observed.The unit was immediately disconnected from the wall and physically removed from the operating theatre.The procedure was not completed as alternate equipment was not available.A monopolar button electrode was used with another diathermy generator to coagulate any bleeding and the procedure was then abandoned.Neither the patient nor the staff have suffered any medical trauma or injury as a result of the issue, however, the patient will require re-treatment.After inspection, there was no obvious damage or abnormalities to the resectoscope or the electrodes used.

Manufacturer Narrative

The device was returned and evaluated, and the customers allegations were confirmed; error 433 was present on the device caused by a faulty high voltage power supply (hvps) and the generator board.The hvps and generator board were replaced with a known working board and confirmed the device powers up correctly.The device was tested in accordance with the service manual and the device passed all tests with the known working hvps fitted.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide the correct to b2 to other and h6 heic to surgical procedure delayed.

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.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, error e433 is triggered by the device¿s safety system and occurs during device startup if the effective value of the output signal which is set for testing falls below the intended limit of 130v.In this reported complaint, error e433 occurred due to a defective generator board and a defective high voltage power supply (hvps) board.Possible causes of the defective generator board are as follows: 1.A defective tr1 transformer on the generator board (permanent error).2.A defective current transformer on the generator board (permanent error).3.A defective impedance transformer on the generator board (permanent error).4.A defective peak rectifier on the generator board (permanent error).5.A missing drive signal for the output stage of the generator board (permanent error).6.The output voltage is too low due to bad switching of the hf output stage on the generator board (permanent error).Possible causes of the defective hvps board are as follows: 1.The supply voltage from the hvps board is missing or too low (permanent error).2.A defective hvps board due to a short circuit of the mos transistors (permanent error).In such cases, the user may observe popping noises or flashes.Furthermore, it is likely that only one component is defective in the case of permanent error patterns.Combined failures are very rare.However, the combined failure of the defective motherboard and the hvps board is known.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿a suitable replacement device must be provided during an application.¿ this supplemental report includes information added to h4.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: 17571171
• MDR Text Key: 321408875
• Report Number: 9610773-2023-02278
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• 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: 08/11/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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
• Treatment: OLYMPUS RESECTOSCOPE AND ELECTRODES
• Patient Outcome(s): Required Intervention; Other