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

Model Number WB91051W

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Output Problem (3005)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

The electrosurgical device esg-400, serial number (b)(4).Returned for evaluation with a customer reported issue of ¿equipment turned on and the display shows error e433¿.Initial evaluation of the device, the service repair reported that the customer reported issue of error e433 was unable to re-create/ not able to be duplicated.However, review of fault log found error e433 showed on the log thirteen times.Additionally, service repair noted that the output power of the bipolar autocoag is less than the limit and needs to be calibrated.Additionally, software upgrade recommended.Unrelated to the reported issue, minor scratches on the frame, dents on the top cover were observed.Service repair noted that since error e433 did not occur as a continuous and endless rebooting cycle and was not duplicated, there is no permanent damage to the unit.Communication with the customer, advised the reported results and the device was calibrated, software was upgraded.Once completed, the device was forwarded to the regulatory rma (ra team) and a functional testing was performed.Functional test found no issue with the device.All the front connectors and footswitch connectors on the rear panel are in good condition.The device is equipped with correct fuses, and all the pc boards and internal wirings appeared to be intact.The generator was checked for functionality together with olympus reference test footswitches (wb50402w and wb50403w), test handpieces for all output modes, and the error e433 did not occur during functional inspection.The generator was burn-in test for additional 2 hours, powered on/off multiple times without any error message observed.The device also passed the contact quality monitor and measurable output inspection.Based on the evaluation findings, the reported complaint was not duplicated.The generator is functional as intended.The possible cause for error e433 could be the following: error e433 can be caused by the following non-intended use scenarios: metal-to-metal sparking, and simultaneous use of two hf surgical generators.Metal to metal sparking: do not bring the tip of the hf instrument close to a metal clip or other accessories.The tissue around the metal clip or the hf instrument may be burned.Simultaneous use of two hf surgical generators: if the electrosurgical generator is used in conjunction with another electrosurgical generator, never use both generators simultaneously.Keep the hf instruments connected to the not-used electrosurgical generator away from the target area while the other generator is in operation.Do not activate both generators simultaneously.Patient or user injury may occur due to the concentration of electric current.Error e433 may also be caused by a faulty footswitch.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported , the device was turned on and the display showed error e433.The issue found during maintenance.There is no patient involvement on this reported event.No user injury reported.

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, there are several likely causes for error e433.When starting the esg-400, the output voltage of the generator board is checked for test purposes.Error message e433 may be displayed if the output voltage does not reach the required value of 120v.The esg-400 generator is then restarted for safety reasons.If the cause of the error remains, there may be an unlimited number of periodic restarts.The likely causes for error e433 are as follows: 1) the user activates the foot switch while the generator is booting.2) faulty foot switch (temporary error).3) faulty foot switch (temporary error, faulty reed contact).4) defective cable connection between hvps board and generator board (temporary or permanent error).5) defective cable connection for the output signal between generator board and relay board (temporary or permanent error).6) defective generator board (permanent error).7) defective hvps board (permanent error).8) defective motherboard (permanent error).9) defective motherboard (permanent error).10) defective relay board (permanent error).This supplemental report includes information added to e2, e3 and g2.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 Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15465618
• MDR Text Key: 306508449
• Report Number: 9610773-2022-00427
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• 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: 09/09/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• 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