MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-19 for ENDO STRATUS CO2 INSUFFLATOR EGA-501 manufactured by Medivators.
[17299095]
The case states that a medivators endo stratus co2 insufflator unit shorted out and shut down in the middle of a procedure. Patient procedure delayed.
Patient Sequence No: 1, Text Type: D, B5
[17523113]
The case states that a medivators endo stratus co2 insufflator unit shorted out and shutdown during a patient procedure. The device was immediately removed from the room and the endoscopy procedure resumed. There was no reported injury to the patient or physician/handler using this machine. Patient procedure delayed. The facility was provided rma information to return the device to medivators. It has yet to be received for further evaluation. This complaint will continue to be monitored within medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651395-2015-00005 |
| MDR Report Key | 4618259 |
| Report Source | 06,07 |
| Date Received | 2015-03-19 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-02-26 |
| Date Mfgr Received | 2015-02-26 |
| Device Manufacturer Date | 2014-05-09 |
| Date Added to Maude | 2015-04-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO STRATUS CO2 INSUFFLATOR |
| Generic Name | ENDOSCOPIC INSUFFLATOR |
| Product Code | FCX |
| Date Received | 2015-03-19 |
| Model Number | EGA-501 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-03-19 |