MAUDE Adverse Event Report: US ENDOSCOPY CO2MPACT; ENDOSCOPIC INSUFFLATOR

Model Number	710300
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The co2efficient endoscopic insufflator is being returned for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the manufacture date is unknown at this time; therefore, the applicable udi and production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that during a patient procedure their co2efficient endoscopic insufflator was not operating properly and subsequently caused "harm" to the patient.The user facility declined to provide additional information regarding the patient.
Additional Manufacturer Narrative
The co2efficient endoscopic insufflator was returned to the supplier for evaluation.Evaluation results determined that when the device was commanded to flow, it would initially run however, the device would then stop flowing.All the buttons on the device's panel also became unresponsive.The co2efficient endoscopic insufflator was recalibrated, tested, and confirmed to be operating to specifications.The device was returned to the user facility, and no additional issues have been reported.

• Brand Name: CO2MPACT
• Common Device Name: ENDOSCOPIC INSUFFLATOR
• 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 ; 4403586251
• MDR Report Key: 22912729
• Report Number: 1528319-2025-00089
• Device Sequence Number: 9110996
• Product Code: FCX
• UDI-Device Identifier: 00724995180362
• UDI-Public: (01)00724995180362(11)220503
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/28/2025

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: 07/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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