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

Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gi4000 electro surgery unit subject of the reported event is being returned to the manufacturer for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, user facility personnel were utilizing the argon plasma coagulation on the gi4000 electro surgery unit and the display screen that shows the endoscope image "blacked out".The patient procedure was subsequently cancelled.No report of injury.
Additional Manufacturer Narrative
The gi4000 electro surgery unit subject of the reported event was returned to the manufacturer for evaluation.Evaluation of the device determined that no issues were noted with the function or operation.The device operated according to specifications and the reported event could not be duplicated.During post-test inspection, it was noted that a "noise" was coming out of the argon regulator.The manufacturer notified the user facility of this observation; however, the user facility declined further repair and requested the gi4000 electro surgery unit be returned to them.The unit has been returned and put back in service.The device history record (dhr) was reviewed and confirmed the device was manufactured to specification; no abnormalities were noted.A complaint review was performed and confirmed this event to be isolated.No additional issues have been reported.

• Brand Name: GI4000 ELECTRO SURGERY 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: 19097044
• Report Number: 1528319-2024-00031
• Device Sequence Number: 7682282
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: 00724995180256
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/12/2024

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
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 09/09/2024
• 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