MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY OLYMPUS ESG-100, 100...120 V~,; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WB991046
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during an endoscopic mucosal resection procedure, the esg-100 generator mode changes while in use, "while using pulse cut slow, it suddenly changed to soft coagulation." there procedure was prolonged less than 30 minutes and was completed using a device from another manufacturer.There were no reports of death or serious injury.
Additional Manufacturer Narrative
Updated fields: d8, d10, h2, h3, h4, h6, and h11.The device was returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, a definitive root cause could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be detected/prevented by following the instructions for use which state: chapter7: operation.Warning.Before each use, inspect this unit as instructed below.Inspect other equipment to be used with this unit as instructed in their respective instructions for use.Should the slightest irregularity be suspected, do not use the electrosurgical unit and refer to chapter 9 (troubleshooting).If the irregularity is still suspected after consulting chapter 9, contact olympus or your distributor.Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.Chapter9: troubleshooting.If the electrosurgical unit has visible damage, do not use the electrosurgical unit and contact olympus or your distributor.If the unit is not functioning properly, use the information in this chapter to identify and correct the malfunction.If the problem cannot be resolved by the described remedial action, stop using the electrosurgical unit and contact olympus or your distributor for repair.Danger.Never use the electrosurgical unit if an abnormality is suspected.The patient can be seriously injured.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; odakura, nishigo-mura,; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; odakura, nishigo-mura,; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20870015
• Report Number: 3003724334-2024-10020
• Device Sequence Number: 8592507
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: WB991046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown