MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CO2MPACT ENDOSCOPIC INSUFFLATOR; INSUFLATTOR

Model Number	710300
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was to be sent to a repair facility (acist) for investigation and necessary repairs.Steris is pending the report of the evaluations.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their co2mpact endoscopic insufflator entire panel is turned on with lights at the half flow resulting in a procedure delay.No patient harm or injury reported.
Additional Manufacturer Narrative
The results of the evaluation performed by the repair facility (acist) determined the unit was out of calibration.The unit was recalibrated, tested, and returned to service.

• Brand Name: CO2MPACT ENDOSCOPIC INSUFFLATOR
• Common Device Name: INSUFLATTOR
• 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: 15670858
• Report Number: 1528319-2022-00056
• Device Sequence Number: 15077338
• Product Code: FCX
• UDI-Device Identifier: 00724995180362
• UDI-Public: 00724995180362
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 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: 10/10/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 02/06/2023
• 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