MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-16 for SOLARGEN 2100S CONSOLE LSR-SG2100S manufactured by Cryolife, Inc..
[25900110]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[25900111]
According to the report, "surgeon was using the hand piece on the patient when the o. R. Light boom went out. Then the solargen lost power. The lights came back on and they tried to plug the laser into another outlet yet the laser still would not work. " the case was delayed.
Patient Sequence No: 1, Text Type: D, B5
[32293769]
According to the report, "surgeon was using the hand piece on the patient when the or light boom went out. Then the solargen lost power. The lights came back on and they tried to plug the laser into another outlet yet the laser still would not work. " the case was delayed. The solargen console was returned to cryolife in its reusable container and unpacked on (b)(4) 2015 for evaluation. An "out of service" tag was placed on the laser by the hospital. The console was opened and the laser cavity was inspected. The optic was visibly damaged. The rest of the laser cavity did not exhibit any signs of damage. The console was connected to power to test basic functionality and turned on without any error codes. Due to the damaged optic, further functionality was not tested. The handpieces which were used during the procedure were also returned for evaluation (sologrip iii handpieces, lot numbers ta-04071-01 and ta-04047-87). The hospital did not note anything specific on the hand pieces, yet they were using them at the time of the incident. The handpieces were visually inspected and no damage was noted to either handpiece. The handpieces were connected to a hene [helium-neon] laser to test output. Both handpieces effectively delivered laser and no damage was noted. The thumb slide mechanisms on both handpieces were functional and the fibers retracted without problem. The manufacturing records for solargen console serial number (b)(4) and sologrip iii handpiece lot numbers ta-04071-01 and ta-04047-87 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record. A review of the available information was performed. On (b)(4) 2015, cryolife was notified that the laser had tripped its internal circuit breaker. As no replacement parts were available, the customer was sent a loaner laser which was installed on (b)(6) 2015. Console (b)(4) was returned to cryolife for service. Previous service reports note that laser (b)(4) had been serviced on the recommended preventive maintenance (pm) schedule. The root cause is the optical cavity (oc) optic failed, which caused the laser to ramp up power to compensate for the deficiency; the built-in safety functions tripped the circuit breaker as they were designed to do. The oc optic was replaced and cleaned, and the optical cavity resonator assembly was aligned for maximum efficiency. The root cause is the optical cavity (oc) optic failed, which caused the laser to ramp up power to compensate for the deficiency; the built-in safety functions tripped the circuit breaker as they were designed to do. The oc optic was replaced and cleaned, and the optical cavity resonator assembly was aligned for maximum efficiency. No issues were noted with the two sologrip iii handpieces which were used during the procedure. The ifu provides the following instructions: "mains power quality should be that of a typical hospital environment," "power requirement for the 115 volt configuration is a 115? 10% vac, 50-60 hz, single-phase dedicated outlet rated at 15 amps," "a dedicated outlet is required for the proper operation of the laser console. Do not plug the laser console into a power strip," and "for major malfunctions, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32293770]
According to the report, "surgeon was using the hand piece on the patient when the or light boom went out. Then the solargen lost power. The lights came back on and they tried to plug the laser into another outlet yet the laser still would not work. " the case was delayed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00228 |
| MDR Report Key | 5080239 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-16 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2015-08-27 |
| Date Added to Maude | 2015-09-16 |
| 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 | ROCHELLE MANEY |
| 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 | 3 |
| Brand Name | SOLARGEN 2100S CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Product Code | MNO |
| Date Received | 2015-09-16 |
| Model Number | LSR-SG2100S |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-09-16 |