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

Model Number G1110001

Device Problem Infusion or Flow Problem (2964)

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

Event Date 12/11/2023

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 332908462
• Report Number: 1528319-2024-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: 00724995180256
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G1110001
• Device Catalogue Number: G1110001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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