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

Model Number 710300

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure the flow rate on their co2mpact endoscopic insufflator was not operating properly.User facility personnel utilized another unit causing a delay in the patient procedure.The procedure was completed successfully, and no injuries were reported.

Manufacturer Narrative

Following the reported event, the device was sent to the manufacturer for evaluations and repairs.The co2mpact endoscopic insufflator® system operator's manual (3180653) provides the user with the following information: "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)." steris is pending the report of the evaluations.A follow-up report will be submitted when additional information becomes available.No additional issues have been reported.

Manufacturer Narrative

The co2mpact endoscopic insufflator was returned to the contract manufacturer for evaluation.During the evaluation of the device, it was found that the unit could not be powered on, and surface damage was noted on the front panel bezel.The power supply, pressure relief valve, and front panel bezel were replaced, and the co2mpact endoscopic insufflator was recalibrated and found to be operating properly.The device was returned to the customer and no additional issues have been reported.

• Brand Name: CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM
• Type of Device: CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM
• 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: 14515524
• MDR Text Key: 300467637
• Report Number: 1528319-2022-00028
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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
• Device Operator: Health Professional
• Device Model Number: 710300
• Device Catalogue Number: 710300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1