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

Model Number WB91051W

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter health professional/initial reporter occupation: selected in error.Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.In speaking with olympus technical assistance center (tac), the customer confirmed that multiple hand pieces and active cords were swapped out but the e006 still occurred when the hand pieces were activated in the universal port.The confirmed that saline was being used with the hand pieces as well.Customer inspected the cord connections and noticed that the active cord wasn't fully connected and after plugging the cord in all the way, the e006 error no longer occurred.As the failure was resolved over the phone, the device was not expected to be returned.Attempts were made to obtain additional information regarding the event but have not been successful.If additional information becomes available, this report will be supplemented.Based on the results of the investigation, the failure occurred as a result of the plug not being inserted correctly as the error code disappeared after the plug had been reinserted.There was no defect in the generator.The occurrence of error e006 can be attributed to various causes, which have all been attributed to the electrical resistance between the two electrodes of the device increases and then the error message is triggered.This error message is intended to warn the user if a rinsing fluid with insufficient conductivity is used.However, since the conductivity of the entire circuit can also be changed by other influences, error e006 is also triggered in this case under certain circumstances.Generally, the following may cause of contribute to this type of event: a growing tissue deposit on the electrode.Increased contact resistance due to poorly or insufficiently plugged contacts on the conveyor or the connecting cable.Increased contact resistance due to defective contacts on the conveyor or the connecting cable.This can occur especially if the instruments are not correctly connected and the generator has been activated.A contact damaged in this way does not necessarily have to lead to a failure pattern immediately, but it can also decline in the further course, so that the error message described only occurs later.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus technical assistance center (tac), when activating the hand pieces on the hf unit "esg-400" with the foot switch, an e006, insufficient conductivity error occurred.The intended procedure had been therapeutic.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information from the reporter, refer to e2.E3 and g2.

Event Description

According to the reporter, no further information is available.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3003724334.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15463164
• MDR Text Key: 306169041
• Report Number: 9610773-2022-00426
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 01/24/2023; 06/24/2024
• Supplement Dates FDA Received: 01/24/2023; 06/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2022
• 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