| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CARDIOGENESIS CORPORATION | MNO | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-12-22 | 0 | 1. O |
Patient 1
DURING A PREVENTATIVE MAINTENANCE ON TMR LASER ((B)(4)),THE LASER WOULD SHUT DOWN IF THE KEY WAS FLEXED IN THE KEY SWITCH. THE LASER SYSTEM IS 15 YEARS OLD AND IT IS NOT UNUSUAL FOR THE SWITCH TO WEAR IN THIS MANNER. THE KEY SWITCH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE COMPLAINANT STATED THAT SHE HAD NOT HAD ANY INCIDENT OF SYSTEM SHUT DOWN.
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Patient 1
CRYOLIFE WAS INFORMED THAT DURING A PREVENTATIVE MAINTENANCE (PM) ON TRANSMYOCARDIAL REVASCULARIZATION (TMR) LASER (S#(B)(4)), THE LASER WOULD SHUT DOWN IF THE KEY WAS FLEXED IN THE KEY SWITCH. THE LASER SYSTEM IS 15 YEARS OLD AND IT IS NOT UNUSUAL FOR THE SWITCH TO WEAR IN THIS MANNER. THE KEY SWITCH WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO USER COMPLAINT OF THIS HAPPENING AND SPECIALTY TEAM MANAGER FOR CARDIAC SURGERY, (B)(6) STATED THAT SHE HAD NOT HAD ANY INCIDENT OF SYSTEM SHUT DOWN. A REPORT WAS ISSUED STATING THAT THERE IS NOT A SERVICE CONTRACT WITH THE ACCOUNT AND THEREFORE NO PREVIOUS SERVICE RECORDS EXIST ON FILE FOR THE LASER. CRYOLIFE ISSUED A NO CHARGE PURCHASE ORDER (PO) FOR A ONE TIME PREVENTATIVE MAINTENANCE ON THE UNIT AS THE HOSPITAL HAD REQUESTED THE SYSTEM BE CHECKED OUT SINCE IT HAD NOT BEEN DONE IN SOME TIME. THE EVENT COULD BE DUPLICATED BY MANIPULATING THE KEY IN THE KEY SWITCH, WHICH WOULD CAUSE SYSTEM TO CYCLE OFF. THERE WAS NO FURTHER INSPECTION OF THE KEY SWITCH AND DIAGNOSTICS AFTER REPLACING THE FAULTY KEY SWITCH. WORN KEY SWITCH WAS REPLACED WITH A NEW KEY SWITCH (SP2276) DURING THE SCHEDULED ROUTINE PREVENTATIVE MAINTENANCE CYCLE. THERE WAS NO EVIDENCE TO SUGGEST THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. 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. THERE WERE NO PROBLEMS REQUIRING CORRECTIVE ACTION DOCUMENTED ON THE FINAL PRODUCT CORRECTIVE ACTION LIST PORTION OF THE FINAL TEST/QUALITY ASSURANCE PROCEDURE. THERE WERE NO ADDITIONAL NON-CONFORMANCES OR REWORKS INCLUDED IN THE MANUFACTURING AND FINAL INSPECTION RECORDS.
Patient 1
DURING A PREVENTATIVE MAINTENANCE ON TMR LASER (S#(B)(4)),THE LASER WOULD SHUT DOWN IF THE KEY WAS FLEXED IN THE KEY SWITCH. THE LASER SYSTEM IS 15 YEARS OLD AND IT IS NOT UNUSUAL FOR THE SWITCH TO WEAR IN THIS MANNER. THE KEY SWITCH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE COMPLAINANT STATED THAT SHE HAD NOT HAD ANY INCIDENT OF SYSTEM SHUT DOWN.