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

Model Number WB91051W

Device Problems Output Problem (3005); Noise, Audible (3273)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated at olympus service business center (sbc) service repair.An error e194 was observed and noted to be due to defective generator board.The customer reported issue of error e194 was confirmed.Service repair noted the generator board needs to be replaced and software version needs to be upgraded.Legal manufacturer investigation results: the product was sold on (b)(6) 2020.Analysis: the occurrence of error message e194 was reported.The inspection carried out by olympus service business center (sbc) identified the generator board as the cause of the reported error.During the output of the high voltage (activation), the esg-400 regularly monitors the occurrence of leakage currents.For this purpose, the effective value of the difference between outgoing and incoming current is determined on the generator board.If the determined leakage current is too high, the error message e194 is triggered and for safety reasons, it is then no longer possible to activate the unit until the error has been rectified.The error message e194 is to be understood as a warning to the user and serves to protect the patient and the user.Under no circumstance will it be triggered by a faultless esg-400 during normal operation.Possible causes from the user's point of view: 1.The patient has ground contact due to incorrect patient positioning (temporary or permanent error).2.The user creates a ground connection with the instrument during activation (temporary or permanent error).Please note that incorrect patient positioning with ground contact can cause burns to the patient.Possible technical causes of the error may be: 1.A defective current transformer on the generator board (permanent error).2.A defective impedance transformer on the generator board (permanent error).3.A defective rms converter on the generator board (permanent error).4.A defective output amplifier for the rms converter on the generator board (permanent error).5.A defective adc on the motherboard (permanent error).It is important to mention that if error message e194 occurs during an application, the user must first check the patient positioning and correct the error.However, if the error message e194 occurs more frequently or even permanently, the esg-400 should be subjected to a technical inspection.In this case, the generator board should first be checked in another esg-400 with regards to error message e194.If the error is confirmed, the generator board must be replaced.If the generator board is ok, then the motherboard must be checked and replaced if necessary.Please note that replacing one of the two components based on suspicion is not meaningful.If the error message e194 is listed in the error log and cannot be duplicated, it is very likely that a use error has occurred.In this case, a complete safety check (psc) must be carried out in accordance with the current service manual before delivery to the customer.The sbc has identified the generator board as the cause of the reported issue.Device history record review (dhr) : a manufacturing and quality control review was performed for device wb91051w with serial number (b)(4).There is no non-conformity associated with this device with respect to the described issue.The dhr review showed that the device was manufactured according to valid instructions and met all specifications.Olympus will continue to monitor complaints for this device.

Event Description

The customer facility site biomedical engineer sent a repair request reported with an issue of "it makes a terrible noise when turn it on, error code 194 (ref.E132 error), generator needs to be replaced ".The issue found during an unknown event.There was no patient harm, no user injury reported due to 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 Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15499973
• MDR Text Key: 306408357
• Report Number: 9610773-2022-00447
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/28/2022

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: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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