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 01/15/2024

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The physician reported to olympus that 5 minutes into the therapeutic, transurethral resection of the prostate procedure, when using hf unit "esg-400", an error code e433 was displayed on the screen indicating that the device will restart.The device was restarted, disconnected, and reconnected and the same error message was displayed.As such the procedure was delayed by 45 minutes wherein another team was brought in.The procedure was completed with another device as the facility had a similar device which was used to finish the procedure and patient's condition was not affected by the failure.A.Reportedly the old equipment did not have the same vigorous coagulation and cutting.No medical interventions were reported because of the reported problem.There were no reports of patient harm.The device was not inspected before use it was only disconnected to reconnect.

Event Description

It was reported that the patient was bleeding which gave the opportunity to bring another team.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out.Additionally, to provide correction to field.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed as the device passed inspection test.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, it is likely the error message e433 transpired which led to the procedure being delayed due to the following: 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).4) defective foot switch (temporary error, defective reed contact).5) defective cable connection between the high voltage power supply (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 transient voltage suppressor (tvs) diodes on the relay board (permanent error).15) defective transformer tr1 on the generator board (permanent error).16) defective hvps board due to short circuit of the metal-oxide-semiconductor (mos) transistors (permanent error).However, a specific root cause of the reported event could not be identified.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, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18552811
• MDR Text Key: 333364999
• Report Number: 9610773-2024-00219
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2020
• 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
• Patient Outcome(s): Other
• Patient Sex: Male