MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for ENDOSTRATUS CO2 INSUFFLATOR EGA-501 manufactured by Medivators.
[61086538]
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.
Patient Sequence No: 1, Text Type: N, H10
[61086539]
The facility reports that patients are experiencing post procedure abdominal pain and pressure after using co2 insufflator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651395-2016-00008 |
| MDR Report Key | 6133860 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-28 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2016-11-01 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2016-11-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEGAN DICKEY |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 3150 POLLOK DR |
| Manufacturer City | CONROE TX 77303 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77303 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOSTRATUS CO2 INSUFFLATOR |
| Generic Name | CO2 INSUFFLATOR FOR ENDOSCOPE |
| Product Code | FCX |
| Date Received | 2016-11-29 |
| Returned To Mfg | 2016-11-07 |
| Model Number | EGA-501 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOK DR CONROE TX 77303 US 77303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-29 |