MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-22 for SOLARGEN 2100S TRANSYMOCARDIAL REVASCULARIZATION LASER CONSOLE SG-2100S manufactured by Cardiogenesis Corporation.
[21332473]
The laser involved was the solargen serial # (b)(4). The system generated the error #16 when they first turned on the unit prior to doing the case, they than restarted the laser system and was able to complete the case without any error codes.
Patient Sequence No: 1, Text Type: D, B5
[21687133]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[29230840]
The laser involved was the solargen console serial number (b)(4). The system generated the error 16 (which indicates the energy delivered form the holmium laser was too high) when the hospital first turned on the unit prior to doing the case. The hospital then restarted the laser system and was able to complete the case without any error codes. Additional information was received from the cryolife representative. The hospital has not had an error 16 with the console before. The hospital has not had cryolife service this console after the appearance of error 16, to date. The hospital does not have a service agreement with cryolife and the hospital's biomedical department has historically taken care of all the servicing needs of the console. The error caused a delay in the surgery. A review of manufacturing records for laser console (b)(4) was performed in response to this complaint. According to the device history record (dhr) for solargen console (b)(4), all manufacturing procedures and final testing performed at new star laser are documented as being completed and verified by new star's quality control document prior to its release. The system is documented as being able to proceed through the start-up sequence successfully, and calibration was completed. All tests results recorded from the calibration tests are within specification showing the laser console was functioning properly at the time of release for distribution. There are no non-conformances or reworks included in the records. Since the account does not have a current service agreement with cryolife, cryolife has no way to determine if the laser has been properly serviced and calibrated to the recommended specifications. The root cause for this complaint is unknown but is most likely the laser was not maintained per recommendations by cryolife. The ifu states, "non-routine maintenance and all servicing of the solargen 2100s laser such as installation, calibration and repair should only be performed by authorized representatives. It is recommended that maintenance of the solargen 2100s laser console, including system calibration be performed twice annually. " there is no indication that an error or deficiency occurred at cryolife.
Patient Sequence No: 1, Text Type: N, H10
[29230841]
The laser involved was the solargen console serial number (b)(4). The system generated the error 16 (which indicates the energy delivered form the holmium laser was too high) when the hospital first turned on the unit prior to doing the case. The hospital then restarted the laser system and was able to complete the case without any error codes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950727-2014-00027 |
| MDR Report Key | 4352883 |
| Report Source | 06,07 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-11 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2014-12-11 |
| Date Added to Maude | 2015-01-09 |
| 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 | 0 |
| Event Location | 0 |
| 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 | CARDIOGENESIS CORPORATION |
| 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 | 3 |
| Brand Name | SOLARGEN 2100S TRANSYMOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER SYSTEM |
| Product Code | MNO |
| Date Received | 2014-12-22 |
| Model Number | SG-2100S |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOGENESIS CORPORATION |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-22 |