MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GI4000 ELECTROSURGICAL UNIT

Model Number	G1110001
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure that the argon to their gi4000 electrosurgical unit was not firing (delivering argon) as expected.The user facility was not able to complete the case with the gi4000 esu.No report of injury.
Additional Manufacturer Narrative
The gi4000 esu unit subject of the event will be returned to the repair facility, cintron, for evaluation.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device was returned and evaluated by the repair facility.The reported event could not be duplicated.The unit was found to be operating properly and no repairs were required.The user manual for the gi4000 esu states, "when a fault displays on the screen, reset the gi4000 esu by turning the power on/off switch off and back on.If the fault clears the screen, the gi4000 esu can be put back into service.If the fault does not clear from the screen, contact steris customer service at (b)(6) or your local steris endoscopy electrosurgery specialist for a repair or replacement.The gi4000 esu should undergo preventive maintenance testing annually." no additional issues have been reported.

• Brand Name: GI4000 ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 18485378
• Report Number: 1528319-2024-00002
• Device Sequence Number: 9033715
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: 00724995180256
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: G1110001
• Device Catalogue Number: G1110001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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