MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CO2EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM

Model Number 710302

Device Problem Obstruction of Flow (2423)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Following the reported event, the device was sent to the manufacturer for evaluations and repairs.The coefficient endoscopic insufflator® system operator's manual (732223) gives the user the following information if the unit does not deliver co2.Possible cause: "coefficient endoscopic insufflator flow rate incorrect.To check the coefficient endoscopic insufflator's ability to deliver co2 to the patient, follow these verification steps: after powering-up and making sure that your coefficient endoscopic insufflator is connected to the co2 supply tank, depress the volume reset button, zero will appear in the volume liters display.Set the mode selector switch to free flow.Disconnect the tubing set if connected.Press the flow stop/run button to start.Using a wrist watch with a second hand or a stop watch, allow the unit to deliver 3.0 liters of co2.The unit should reach this volume between 50 and 70 seconds.During this time interval, place your finger near the gas output.You should feel co2 exiting from the coefficient endoscopic insufflator".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.

Event Description

The user facility reported that during a patient procedure the flow rate on their coefficient endoscopic insufflator system was low.A procedure delay was reported due to the low flow rate.The procedure was completed successfully and no injuries were reported.

Manufacturer Narrative

In lieu of having the device return to be repaired at steris, the customer spoke with a steris product specialist and were retrained on the instructions concerning flow rate.The customer confirmed that the device was operating to specifications and returned to service.No additional issues have been reported.

• Brand Name: CO2EFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM
• Type of Device: CO2EFFICIENT 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: 14631778
• MDR Text Key: 301261219
• Report Number: 1528319-2022-00030
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 10816765013097
• UDI-Public: 10816765013097
• 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: 06/08/2022

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: 710302
• Device Catalogue Number: 710302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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