MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for SOLARGEN 2100S CONSOLE SG-2100S manufactured by Cryolife, Inc..
[22669002]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[22669003]
According to the notification received by field assurance , the laser foot pedal was not recognized by laser. There was no injury to the patient. The procedure was completed by holding the wire into the foot pedal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00124 |
| MDR Report Key | 4931189 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2015-07-17 |
| Date Added to Maude | 2015-07-22 |
| 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 | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOLARGEN 2100S CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Product Code | MNO |
| Date Received | 2015-07-22 |
| Model Number | SG-2100S |
| Lot Number | VFC02 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-22 |