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

Model Number WB91051J

Device Problems Output Problem (3005); Activation Problem (4042)

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

Event Type  malfunction  

Event Description

An esg-400 hf-generator was returned to olympus for repair because it is reportedly issuing error e006.There is no indication that the reported error occurred during a procedure and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device has already been returned to olympus.However, since the evaluation/investigation is still ongoing, the exact cause of the user's experience and the reported phenomenon has not been determined yet.This report will be updated if additional significant information becomes available or once the evaluation/investigation has been completed.Please note: this report is being submitted although the suspect medical device is not marketed in the usa.However, a similar device is marketed.Model # / catalog #: wb91051w; brand name: electrosurgical generator "esg-400"; common device name: hf-generators; 510(k): k203682; product code: gei.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.According to the physical device inspection/estimation, the reported error could not be reproduced.Also, there were no further problems found.Consequently, the device can be assessed to be in standard.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, a root cause could not be determined.Any error messages that may appear during operation are triggered by the safety system of the esg-400 and communicated visually and acoustically to the user.They are part of the device's own security concept.In particularly critical cases, further use of the device is prevented by the security system until the error has been corrected.The customer is required to check the function of all devices used prior to a procedure.In addition, according to instructions for use (ifu), a suitable replacement device must be provided during an application.Capa-149p-021 is associated with this device with respect to the described issue «display of error code/dubios|e006».Capa-149p-021 was closed on 21.06.2021.Measures were implemented on 21.06.2021.According to the manufacturing date, the device under question is covered by capa-149p-021.Capa root cause: there are several possible causes for e006 error message, all of which are related to an increased resistance between the electrodes of the generator.If this reaches a certain limit, error e006 is triggered, indicating a non-conducting irrigation fluid.This error message is originally intended to warn the user in case irrigation solution of insufficient conductivity is used.Since the conductivity of the whole distance may also be affected by other influences, error e006 may be provoked in other cases as well.The following causes have been identified: 1.A tissue build-up on the electrode 2.Elevated contact resistances due to poorly or insufficiently placed contacts on the working element or the connection cable 3.Elevated contact resistances due to defective contacts on the working element or the connection cable.This may happen in particular if the instruments are not connected correctly and the generator is activated.A contact that was damaged in this way must not necessarily cause a failure immediately, but it may gradually degenerate and may trigger the error message described at a later stage.4.The instrument is inside a gas bubble during activation.In addition, we determined a possible impact of the esg-400 measurement method on the conductivity, whereby a too high measurement voltage may lead to the occurrence of blisters and as a result, the conductivity of the surrounding fluid may be reduced.The possible causes described above have been confirmed as root causes in capa-149p-021.The entire issue regarding error message e006 has been under investigation as part of capa-149p-021.In this context, a software update of the esg-400 has been implemented in april 2017 which improves the test conditions and the averaging calculation during the resistance measurement.For this failure mode, a user error cannot be excluded.In this present case, it can be assumed that error message e006 was triggered by a user error or a defective instrument.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-400"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 16059240
• MDR Text Key: 308470847
• Report Number: 9610773-2022-00766
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051J
• Device Catalogue Number: WB91051J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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