MAUDE Adverse Event Report: US ENDOSCOPY; GI4000 ELECTROSURGICAL UNIT

Model Number	GI4000
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow up with user facility personnel regarding the reported event, they stated that a different electrocautery unit was utilized subsequently causing a short procedure delay.The procedure was completed successfully, and no injuries were reported.Steris offered in-service training on the proper use and operation for the gi4000 esu and arc smart probe and is awaiting a response.The gi4000 electrosurgical unit (esu) was returned to the repair facility (cintron) for evaluation.Investigation of this event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the device subject of the event was manufactured in 2012 prior to udi compliance; therefore, udi is not applicable and was not included in the mdr.
Event or Problem Description
The user facility reported via medwatch mw5162107 that when the electrosurgical unit was on the argon plasma coagulation (apc) setting, a spark was observed from the arc smart probe tip when the apc was engaged.No report of injury.
Additional Manufacturer Narrative
Contrary to the information submitted in mdr # the gi4000 electrosurgical unit (esu) was not returned to the repair facility for evaluation.The user facility requested to have a steris service technician inspect and evaluate the gi4000 esu subject of the reported event onsite.During the technician's evaluation, he found that the screen was dark and flicking as well as multiple components and controllers that required replacement.The technician stated that the label was missing from the top cover and missing zip ties, a clamp on the argon hose to the manifold required replacement and a missing gasket o-ring on the retaining cylinder cap was damaged and required replacement.The technician performed repairs to the gi4000 esu unit, tested the function and operation of the device, and returned it to service.The gi4000 esu was manufactured in 2012 and was approximately 14 years old at the time of the reported event.The gi4000 esu is not under a steris service contract for maintenance activities; the user facility is responsible for all maintenance activities.Steris performed in-service training with user facility personnel on the proper use and operation for the gi4000 esu and arc smart probe.No additional issues have been reported.Udi related data clarification - the device subject of the event was manufactured prior to udi compliance, therefore, udi is not applicable and was not included in the mdr.

• Brand Name: NA
• Common Device Name: GI4000 ELECTROSURGICAL UNIT
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20644515
• Report Number: 1528319-2024-00099
• Device Sequence Number: 20700692
• Product Code: GEI
• UDI-Device Identifier: 00724995180256
• UDI-Public: 00724995180256
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 11/08/2024

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
• Device Model Number: GI4000
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 02/19/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown