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

Model Number WB91051W

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/23/2022

Event Type  malfunction  

Event Description

Olympus was informed by the operating manager at the user facility that the customer high frequency electro-surgical generator unit¿s settings changed on it¿s own during an unspecified procedure."while in cut mode, the unit was set to 30-30 but then the energy settings changed to 300-300." no death or injury has occurred.The device will be returned for service.

Manufacturer Narrative

The subject device was returned to olympus for service.The evaluation did not confirm/duplicate the customer¿s reported issue of the device changing settings on it¿s own.The inspection and testing did observe a faulty alarm system, a damaged front panel and upgrades to the system software and cable are recommended.A review of the device's repair history shows no previous repair records.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the device evaluation.Please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the reported event (display resetting) occurred due to user error.The esg-400 may have different settings for coag and cut modes.Assuming the user accidentally swapped the pedals for cut and coag, it¿s probable the generator activated with a higher mode.However, an acoustic and visual indication of the current mode will be presented to the user.Additionally, it¿s probable that electromagnetic interference caused the generator to malfunction.The root cause of this event was unable to be identified.The instructions for use include: "portable rf communications equipment (including peripherals) should be used no closer than 30 cm (12 inches) to any part of the esg-400, including cables specified by the manufacturer.Otherwise, degradation of the performance of this equipment could result." 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, de 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15087722
• MDR Text Key: 304018913
• Report Number: 9610773-2022-00293
• 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: 12/13/2022

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: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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