MAUDE Adverse Event Report: US ENDOSCOPY CO2MPACT; CO2EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM

Model Number	710300
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was sent to the supplier for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The user facility reported that during a patient procedure their co2 efficient endoscopic insufflator system was intermittently shutting off resulting in a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The co2efficient endoscopic insufflator unit subject of the reported event was returned to steris for evaluation.The reported event could not be duplicated; however, the unit's membrane did not perform as expected.The membrane was replaced and the device was recalibrated and tested prior to being returned to the customer.The co2efficient endoscopic insufflator operator manuals states, "before each use, the following procedures or inspections should be performed: visually inspect the co2mpact endoscopic insufflator® system for external signs of damage.Inspect the electrical connections.Do not use if the inspection reveals damage.Before connecting the power cord to the wall outlet, make sure the main power switch is off and that the voltage is correct.Inspect the connection to the co2supply tank, to assure it is intact and tight." additionally, the co2mpact endoscopic insufflator® system operator's manual (3180653) provides the appropriate gas flow setting for the user: "(3) user-selectable settings: 2.0 (1.8-2.3) liters/minute(low), 2.9 (2.7-3.1) liters/minute (medium), 3.4 (3.2-3.6) liters/minute (high)." a 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: CO2MPACT
• Common Device Name: CO2EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4405197842
• MDR Report Key: 22541037
• Report Number: 1528319-2025-00077
• Device Sequence Number: 17892802
• Product Code: FCX
• UDI-Device Identifier: 00724995180362
• UDI-Public: (01)00724995180362(11)220513
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 07/18/2025

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: 710300
• Device Catalogue Number: 710300
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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