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 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

The electrosurgical device esg-400, serial number (b)(4) was returned for evaluation with a customer reported issue of ¿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 (13) 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 top cover, minor chips, dents and scratches on the front frame were observed, not affecting the device function.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 device inspection results.The device was then calibrated, software was upgraded.Once completed, the device was forwarded to the regulatory rma (ra team, market quality testing area) and a functional testing was performed.Ra investigation : visual inspection found no anomaly on the appearance except for minor scratches, tiny dents as normal wear.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.Legal manufacturer investigation results: investigation is based solely on the information provided by the customer and the service business center (sbc).The product was sold on 01 november 2018.Error e433: the occurrence of error message e433 was reported.The error message was confirmed in the corresponding entries in the error log.However, during the inspection carried out by the service business center (sbc), the reported error could not be duplicated.In this case, it can be assumed that one of the temporary errors listed in the technical cause was the cause for the occurrence of error message e433.The sbc reported insufficient power output at the bipolar output (autocoag).However, the error was corrected after an adjustment.Cause 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 is then restarted for safety reasons.If the cause of the error remains, there may be an unlimited number of periodic restarts.Possible causes are: 1) the user activates the foot switch while the generator is booting (temporary error caused by user action).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 (ntc1, permanent error).9) defective motherboard (adc, permanent error).10) defective relay board (permanent error) device history record (dhr) review: 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 issues.The dhr review showed that the device was manufactured according to valid instructions and met all specifications.The visual defects and minor mechanical damage reported in this complaint, such as scratches or dents on the housing or front panel or unknown deposits on the surface of the device, usually do not affect the electrical function or the safety of the patient and user.Provided there is no evidence of a functional defect or safety risk resulting from such defects, olympus assumes that the device shows normal signs of use.For this reason, such errors have not been explicitly addressed in the above report.Olympus will continue to monitor complaints for this device.

Event Description

As reported, the equipment was being tested prior to performing surgery (therapeutic procedure) and at the time of performing the tests it presents the error e433, for which it cannot be used and the procedure was not continued.There was no patient harm, no user injury reported due to the event.Follow up was made to gather additional information regarding the event reported and to date, no response has been received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response to follow up.Customer rep.Conveyed the following information: it¿s unknown if the procedure has been rescheduled.It is unknown if it was rescheduled, and it is unknown if the device was replaced.Current condition of the patient is unknown.No further information provided.Supplemental report(s) will be submitted should any relevant new information is available and or received.

• 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: 15466667
• MDR Text Key: 306426713
• Report Number: 9610773-2022-00428
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2022

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: 09/09/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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