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

Model Number WB91051W

Device Problems Electrical /Electronic Property Problem (1198); Output below Specifications (3004)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the olympus repair center.The customer¿s reported problem, the device ¿was not outputting enough causing jagged cuts and an insufficient conductivity error occurred constantly¿ could not be confirmed/reproduced.The repair inspection noted the subject device recorded multiple error codes, e172, e646, e486 and e006.Also, the (lvps) cable and power supply board are old and need to be replaced.Additional information was requested from the customer regarding the details of the reported event is pending.The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

The olympus technical support engineer was informed by the biomedical technician at the user facility that the customer high frequency electro-surgical generator (esg) unit reportedly ¿was not outputting enough causing jagged cuts and an insufficient conductivity error (e006) occurred constantly¿.The customer reported event was found during procedure and confirmed no adverse outcome to the patient or other.It is unknown what devices were used, however, when replacing multiple hand pieces and active cords the same issue occurred.Therefore, the customer will be returning the esg unit.The olympus technical support engineer was informed by the biomedical technician at the user facility that the customer high frequency electro-surgical generator (esg) unit reportedly ¿was not outputting enough causing jagged cuts and an insufficient conductivity error (e006) occurred constantly¿.The customer reported event was found during procedure and confirmed no adverse outcome to the patient or other.It is unknown what devices were used, however, when replacing multiple hand pieces and active cords the same issue occurred.Therefore, the customer will be returning the esg unit for repair.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.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, and since no device malfunction was confirmed during evaluation, the definitive root cause of the error e006 and the insufficient power output could not be determined.It is possible that error e006 was caused by growing tissue deposit on the electrode, or increased contact resistance due to insufficiently plugged contacts on the connecting cable or conveyor, or defective contacts.The instruction manual identifies the verbiage for a periodical safety check (psc).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 BERLIN FACILITY; rheinstrasse 8; teltow, breandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15880618
• MDR Text Key: 307996344
• Report Number: 3003724334-2022-00005
• 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
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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