MAUDE Adverse Event Report: MEDIVATORS ENDOSTRATUS CO2 INSUFFLATOR; CO2 INSUFFLATOR FOR ENDOSCOPE

Model Number	EGA-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	11/01/2016
Additional Manufacturer Narrative
The case reported that patients are experiencing abdominal pain and pressure after procedures where the endostratus co2 insufflator was being used.(b)(4) sales representative is in close contact with this facility.This facility was performing regular colon screenings and it was reported that the extent of the pain and pressure the patients experienced was similar to that of procedures done using normal room temperature air.There were no lasting effects or hospitalization of these patients.The endostratus co2 insufflator unit was returned for additional inspection and functionality tests by (b)(4) depot service department.The unit performed according to specification.There is no details confirming that the facility co2 connection or processing error could be the cause.This complaint will continue to be maintained by (b)(4) complaint handling system.
Event or Problem Description
The facility reports that patients are experiencing post procedure abdominal pain and pressure after using co2 insufflator.

• Brand Name: ENDOSTRATUS CO2 INSUFFLATOR
• Common Device Name: CO2 INSUFFLATOR FOR ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• MDR Report Key: 6133860
• Report Number: 1651395-2016-00008
• Device Sequence Number: 153532
• Product Code: FCX
• UDI-Device Identifier: 00677964063671
• UDI-Public: 00677964063671
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 11/28/2016

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: No Information
• Device Model Number: EGA-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1