MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-05-21 for INVISIO DIGITAL CONTROLLER WITH DVI IDC-1500 manufactured by Gyrus Acmi, Inc..
[3567339]
It was reported that the device failed in the middle of the procedure. It did not have any image display on the monitor. The user performed all the recommended checks, and was unable to improve the conditions. The pt was sedated throughout the troubleshooting period. The procedure was eventually aborted due to the camera unit that failed without any pt injury.
Patient Sequence No: 1, Text Type: D, B5
[10739475]
At the time of this report, multiple attempts to obtain further info from the hospital have been unsuccessful, and the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further info becomes available, gyrus scmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218764-2013-00002 |
| MDR Report Key | 3129821 |
| Report Source | 06,07 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-04-22 |
| Date of Event | 2013-04-22 |
| Date Mfgr Received | 2013-04-22 |
| Date Added to Maude | 2013-05-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01722 |
| Manufacturer Country | US |
| Manufacturer Postal | 01722 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | 300 STILLWATER |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISIO DIGITAL CONTROLLER WITH DVI |
| Generic Name | INVISIO DIGITAL CONTROLLER WITH DVI |
| Product Code | KQM |
| Date Received | 2013-05-21 |
| Model Number | IDC-1500 |
| Catalog Number | IDC-1500 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 300 STILLWATER STAMFORD CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-21 |