| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TMR2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CARDIOGENESIS CORPORATION | MNO | LSR-TMR2000 | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-01 | 0 |
Patient 1
ACCORDING TO THE REPORT, DURING PREVENTATIVE MAINTENANCE ON THE TMR LASER, THE SYSTEM SHUT DOWN. THE EVENT COULD BE DUPLICATED BY FLEXING THE KEY IN THE KEY SWITCH. THE KEY SWITCH WAS REPLACED AND THE ISSUE RESOLVED. NO USER COMPLAINT HAS BEEN RECEIVED.
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.
Patient 1
ACCORDING TO THE REPORT, DURING PREVENTATIVE MAINTENANCE ON THE TMR LASER THE SYSTEM SHUT DOWN. THE EVENT COULD BE DUPLICATED BY FLEXING THE KEY IN THE KEY SWITCH. THE KEY SWITCH WAS REPLACED AND THE ISSUE RESOLVED. NO USER COMPLAINT HAS BEEN RECEIVED. DURING THE PREVENTATIVE MAINTENANCE, THE EVENT COULD BE DUPLICATED BY MANIPULATING THE KEY IN THE KEY SWITCH, WHICH WOULD CAUSE THE SYSTEM TO CYCLE OFF. THE WORN KEY SWITCH WAS REPLACED DURING THE SCHEDULED PREVENTATIVE MAINTENANCE. THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON 03/16/2014 AND NOTHING OUTSTANDING WAS NOTED. THE REVIEW OF THE PAST SERVICE HISTORY SHOWED A CHILLER REPLACEMENT ON 12/27/2010 AND AGAIN ON 12/05/2011. NOTHING ELSE WAS NOTED DURING THE REVIEW. AVAILABLE RECORDS WERE REVIEWED FOR COMPLETION AND ANY EVIDENCE OF A MANUFACTURING ERROR WHICH WOULD LEAD TO THE GENERATION OF THIS COMPLAINT. ACCORDING TO DOCUMENTATION, ALL MANUFACTURING PROCEDURES WERE COMPLETED FOR THE FINAL ASSEMBLY OF LASER CONSOLE 20383 EXCEPT THE RECONFIGURING OF THE CONSOLE TO THE EUROPEAN WIRING CONFIGURATION. FUNCTIONAL AND SAFETY TESTS WERE PERFORMED ON THE CONSOLE. ALL STEPS OF THE QUALITY ASSURANCE VERIFICATION WERE COMPLETED, INCLUDING A STARTUP OF THE CONSOLE VIA THE KEY SWITCH, AS WELL AS THE FINAL TEST LASER POWER OUTPUT WITH ALL RESULTS BEING WITHIN SPECIFICATION RANGES. A ROOT CAUSE COULD NOT BE DETERMINED AS LASER CONSOLE 20383 IS DOCUMENTED AS HAVING MET ALL SPECIFICATIONS WHEN IT WAS RELEASED.
Patient 1
ACCORDING TO THE REPORT, DURING PREVENTATIVE MAINTENANCE ON THE TMR LASER THE SYSTEM SHUT DOWN. THE EVENT COULD BE DUPLICATED BY FLEXING THE KEY IN THE KEY SWITCH. THE KEY SWITCH WAS REPLACED AND THE ISSUE RESOLVED. NO USER COMPLAINT HAS BEEN RECEIVED.