MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-27 for TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE TMR-2000 manufactured by Cryolife, Inc..
[16183623]
According to the report, the tmr 2000 at (b)(6) is showing error code 17 when the foot pedal is depressed. Rick spoke with the customer and "the laser did fire. " the last time cryolife serviced the laser was on (b)(4) 2013. The customer owns the console and there is not a service agreement in place. Error code 17 is "power too low" and the customer had the laser set at 46% and 7 watts. Additional information from the representative stated that "no one has been servicing the laser" and the hospital had never seen error code 17 before. The planned procedure was a coronary artery bypass graft (cabg) and transmyocardial revascularization (tmr). Statements from the hospital indicated, "yes, the procedure was delayed because the laser malfunctioned. Yes, there was a point when the surgeon stopped working because the laser was not working. We also opened a second disposable to ensure that the machine was actually the problem," and "the tmr portion of the procedure was aborted because of the malfunction. "
Patient Sequence No: 1, Text Type: D, B5
[16348967]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[35624030]
According to the report, the tmr 2000 at (b)(6) hospital is showing error code 17 when the foot pedal is depressed. (b)(6) spoke with the customer and "the laser did fire. " the last time cryolife serviced the laser was on (b)(6) 2013. The customer owns the console and there is not a service agreement in place. Error code 17 is "power too low" and the customer had the laser set at 46% and 7 watts. Additional information from the representative stated that "no one has been servicing the laser" and the hospital had never seen error code 17 before. The planned procedure was a coronary artery bypass graft (cabg) and transmyocardial revascularization (tmr). Statements from the hospital indicated, "yes, the procedure was delayed because the laser malfunctioned. Yes, there was a point when the surgeon stopped working because the laser was not working. We also opened a second disposable to ensure that the machine was actually the problem," and "the tmr portion of the procedure was aborted because of the malfunction. " the available work order file was reviewed. According to documentation, all manufacturing procedures were completed for the final assembly of laser console 20446 except the reconfiguring of the console to european wiring configuration. All in-process functional and safety tests were conducted on the console and all testing, including final calibration, were performed with all results being within specification ranges. All quality assurance verification tasks were completed. After review of the manufacturing records no root cause could be determined. Though the console was released with a hi output reading of calibration 43% at 6 watts, calibration testing was performed during installation at the customer site and during preventative maintenance service calls to assure the console met specifications. A review of the service records for the console showed it was performing within specification at the time of installation ((b)(6) 2000) and had no other instances of service related issues aside from error code 17 in 2000 and 2015. The account did not have an active service agreement with cryolife for the console. 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.
Patient Sequence No: 1, Text Type: N, H10
[35624031]
According to the report, the tmr 2000 at (b)(6) hospital is showing error code 17 when the foot pedal is depressed. (b)(6) spoke with the customer and "the laser did fire. " the last time cryolife serviced the laser was on (b)(6) 2013. The customer owns the console and there is not a service agreement in place. Error code 17 is "power too low" and the customer had the laser set at 46% and 7 watts. Additional information from the representative stated that "no one has been servicing the laser" and the hospital had never seen error code 17 before. The planned procedure was a coronary artery bypass graft (cabg) and transmyocardial revascularization (tmr). Statements from the hospital indicated, "yes, the procedure was delayed because the laser malfunctioned. Yes, there was a point when the surgeon stopped working because the laser was not working. We also opened a second disposable to ensure that the machine was actually the problem," and "the tmr portion of the procedure was aborted because of the malfunction. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00036 |
| MDR Report Key | 4639064 |
| Report Source | 06,07 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-03-05 |
| Device Manufacturer Date | 2000-01-21 |
| Date Added to Maude | 2015-04-30 |
| 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 | 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 | TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Product Code | MNO |
| Date Received | 2015-03-27 |
| Model Number | TMR-2000 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2015-03-27 |