| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PEARL 5.0 HANDPIECE | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE | CARDIOGENESIS CORPORATION | MNO | HP-PRL5 | TA-04009 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-09-22 | 0 | 1. O |
Patient 1
ACCORDING TO THE REPORT, THE SURGEON COMPLETED A ROBOTIC TMR PROCEDURE WHERE TWO PEARL 5.0 HANDPIECES BROKE. AFTER APPROXIMATELY 12 CHANNELS, THE FIBER BROKE ON THE TIP OF THE FIRST HANDPIECE. THERE WAS A SLIGHT DELAY IN PROCEDURE WHILE A SECOND HANDPIECE WAS OPENED FOR USE. AFTER APPROXIMATELY 25 CHANNELS, THE TIP BROKE ON THE SECOND HANDPIECE. A TOTAL OF 37 CHANNELS WERE PLACED. THIS REPORT REPRESENTS THE SECOND HANDPIECE.
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Patient 1
ACCORDING TO THE REPORT, THE SURGEON COMPLETED A ROBOTIC TMR PROCEDURE WHERE TWO PEARL 5.0 HANDPIECES BROKE. AFTER APPROXIMATELY 12 CHANNELS, THE FIBER BROKE ON THE TIP OF THE FIRST HANDPIECE. THERE WAS A SLIGHT DELAY IN PROCEDURE WHILE A SECOND HANDPIECE WAS OPENED FOR USE. AFTER APPROXIMATELY 25 CHANNELS, THE TIP BROKE ON THE SECOND HANDPIECE. A TOTAL OF 37 CHANNELS WERE PLACED. THIS REPORT REPRESENTS THE SECOND HANDPIECE.
Patient 1
ACCORDING TO THE REPORT, THE SURGEON COMPLETED A ROBOTIC TMR PROCEDURE WHERE TWO PEARL 5.0 HANDPIECES BROKE. AFTER APPROXIMATELY 12 CHANNELS, THE FIBER BROKE ON THE TIP OF THE FIRST HANDPIECE. THERE WAS A SLIGHT DELAY IN PROCEDURE WHILE A SECOND HANDPIECE WAS OPENED FOR USE. AFTER APPROXIMATELY 25 CHANNELS, THE TIP BROKE ON THE SECOND HANDPIECE. A TOTAL OF 37 CHANNELS WERE PLACED. THIS REPORT REPRESENTS THE SECOND HANDPIECE. THE HANDPIECE WAS RETURNED FOR EVALUATION. THE OBSERVED DAMAGE IS INDICATIVE OF USER MISHANDLING. HANDPIECE TA-04009-04 HAD MULTIFILAMENT FIBERS THAT HAD BROKEN AND MELTED THROUGH THE PLASTIC. THIS DAMAGE IS CONSISTENT WITH DAMAGE SEEN BY BENDING THE SHAFT TOO SHARPLY. WHEN THE LASER IS PULSED, EXTREME HEAT IS PRODUCED RESULTING IN BREAKAGE OF THE FIBER BUNDLE IF THERE IS A SHARP BEND IN THE FIBER. A RECORD REVIEW WAS PERFORMED FOR THE LOT. THE LOT WAS CONSTRUCTED FROM APPROVED COMPONENTS AND MET ALL SPECIFICATIONS. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THE IFU STATES "EXCESSIVE STRESS OR TENSION ON THE OPTICAL FIBER CONTAINED IN THE HANDPIECE MAY RESULT IN DEVICE DAMAGE OR MALFUNCTION. DO NOT GRIP THE OPTICAL FIBER DURING TESTING OR OPERATION. DO NOT BEND THE OPTICAL FIBER AT SHARP ANGLES. IF BREAKS OR FRACTURES APPEAR IN THE OPTICAL FIBER, IMMEDIATELY DISCONTINUE USE AND REPLACE WITH A NEW HANDPIECE."