MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. gi4000 Electrosurgical Unit

Model Number	gi4000
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported during a patient procedure their gi4000 electrosurgical unit ¿would not cut¿.The procedure was completed successfully utilizing an additional device.Report of procedure delay.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event is being returned for evaluation.Investigation in progress.A follow-up report will be submitted when additional information becomes available.

• Brand Name: gi4000 Electrosurgical Unit
• Common Device Name: gi4000 Electrosurgical Unit
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50147366
• Report Number: 1528319-2026-00095
• Device Sequence Number: 9341462
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: (01)00724995180256
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: gi4000
• Device Catalogue Number: G1110001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/05/2026
• 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