MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-03 for SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE manufactured by Cardiogenesis Corporation.
[4795726]
Reported laser shut down during case. I contacted account. They said laser shut down after 40 channels. They tried a separate plug and cord, but were unable to turn on the laser.
Patient Sequence No: 1, Text Type: D, B5
[12242751]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[35010621]
Reported laser shut down during case. I contacted account and spoke to (b)(6) (nurse in or during case). She said laser shut down after 40 channels. They tried a separate plug and cord, but were unable to turn on laser. Additional information was received on this incident from (b)(6), the perfusionist in the room when the event occurred. There was no patient impact as 40 channels were completed and the surgeon, dr. (b)(6) determined this was sufficient. Additionally, the type and serial number of the laser console was identified as sg-2100 and (b)(4), respectively. Dr. (b)(6) was doing a tmr procedure and the laser console shut down (powered off). They tried to turn the console on, tried a different outlet and plug, but the laser console would not turn on. The plug was found to be hot. Dr (b)(6) asked and was told that he was on tmr laser channel 40 and determined that was sufficient. Dr (b)(6) was continuously firing laser while completing the 40 channels with no rest between. (b)(6),the nurse tech in room, stated that laser was plugged into a red emergency outlet, not a dedicated outlet. When a service engineer arrived to service laser, he found one of the 15a breakers on the rear of laser was tripped. After resetting breaker, he tested laser and found it to be working within factory specification (no change from previous service in june 2014). I replaced both 15a breakers on the rear of laser (every time a breaker trips it weakens. These were replaced as a precaution due to this). The most likely root cause to the reported event is the console was plugged in to a non- dedicated outlet. The ifu provides the following instructions if the laser console shuts down, "possible cause: wall outlet circuit breakers tripped off. Major system fault occurred. Solution: check facility wall circuit breakers and reset. Check laser circuit breakers and reset. Contact customer service. " the ifu also states "a dedicated outlet is required for the proper operation of the laser console. " a review of the manufacturing and service records has been performed. There is no indication that an error or deficiency occurred at cryolife.
Patient Sequence No: 1, Text Type: N, H10
[35010622]
Reported laser shut down during case. I contacted account. They said laser shut down after 40 channels. They tried a separate plug and cord, but were unable to turn on the laser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950727-2014-00024 |
| MDR Report Key | 4137549 |
| Report Source | 07 |
| Date Received | 2014-10-03 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-26 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-10-15 |
| 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 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER SYSTEM |
| Product Code | MNO |
| Date Received | 2014-10-03 |
| 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 | 2014-10-03 |