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

Model Number	G1110001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is in process.A follow up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure which included use of their gi4000 electrosurgery unit the cauterization was not working and the screen to the esu went black.A procedure delay occurred as user facility personnel had to utilize another electro surgery unit.No report of patient harm.
Additional Manufacturer Narrative
The gi4000 electro surgery unit was returned for evaluation, and it was found that the screen display was not operating properly and required replacement.Additionally, it was identified that the retaining cylinder and gasket o-ring were damaged and required replacement.The necessary components were replaced, the unit was tested and found to be operational, and it was returned to service.No additional issues have been reported.

• Brand Name: GI4000 ELECTROSURGERY UNIT
• Common Device Name: ELECTROSURGERY 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: 14172182
• Report Number: 1528319-2022-00021
• Device Sequence Number: 12014870
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: 00724995180256
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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