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

Model Number 710300

Device Problems Insufficient Information (3190); Activation Problem (4042)

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

Event Date 09/27/2022

Event Type  malfunction  

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 Description

The user facility reported that their co2mpact endoscopic insufflator front panel is not functioning properly resulting in a procedure delay.No patient harm or injury reported.

Manufacturer Narrative

Results of the evaluation determined that the unit's cpu board, the membrane panel, and the lower valve were damaged.The unit was repaired, tested, found to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: CO2MPACT ENDOSCOPIC INSUFFLATOR
• Type of Device: 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: 15670646
• MDR Text Key: 303657259
• Report Number: 1528319-2022-00055
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 00724995180362
• UDI-Public: 00724995180362
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• 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: 10/10/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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