N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 6295924
- MDR report key
- 6295924
- Report number
- 1063481-2017-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-30
- Date received
- 2017-02-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROCHELLE MANEY
- Address
- 1655 ROBERTS BLVD. KENNESAW GA 30144 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SOLOGRIP III HANDPIECE | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION | CRYOLIFE, INC. | MNO | HP-SG3 | TA-04095 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-02 | 0 | 1. O |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORT, "[THE COMPLAINANT] REPORTED TO ME THAT WHEN THEY PLUGGED IN THE TMR SOLOGRIP HANDPIECE, IT DID NOT HAVE ANY POWER GOING THROUGH IT WHEN THEY TEST FIRED IT. THEY PUT IT ASIDE AND USED ANOTHER HANDPIECE WHICH WORKED FINE. SHE KEPT THE UNIT IN QUESTION AND WILL RETURN WHEN WE REQUEST IT."
N
Patient 1
ADDITIONAL INFORMATION - SAMPLE EVALUATION ONE HAND PIECE, LOT NUMBER TA ? 04095, SERIAL NUMBER (B)(4), WAS RETURNED TO CRYOLIFE. THE HOSPITAL RETURNED THE HAND PIECE IN THE CRYOLIFE-SUPPLIED RETURN KIT. UPON INITIAL INSPECTION, NO DAMAGE WAS NOTED TO THE DISTAL TIP, HANDPIECE, MONOFILAMENT AND MULTIFILAMENT FIBER SHEATHS, EXTENDER NUT CONNECTOR, OR EXTERIOR OF THE COUPLER. THE HANDPIECE WAS CONNECTED TO THE HENE LASER (MODEL 25-LHR-121-249, SERIAL NUMBER (B)(4)) TO DETECT BREAKAGE IN THE MONOFILAMENT OR MULTIFILAMENT FIBERS. THE HANDPIECE DID NOT EFFECTIVELY DELIVER LIGHT ENERGY, INDICATING A BREAKAGE SOMEWHERE IN THE FIBERS. WHILE IT IS NORMAL TO SEE A SMALL AMOUNT OF LIGHT ENERGY WITHIN THE COUPLER BETWEEN THE MONOFILAMENT AND MULTIFILAMENT FIBERS, A GREATER THAN NORMAL AMOUNT OF LIGHT ENERGY WAS SEEN INSIDE THE COUPLER. THE HANDPIECE WAS PICKED UP BY A FIELD ASSURANCE ASSOCIATE AND THE MULTIFILAMENT FIBER DISCONNECTED FROM THE COUPLER. THE COUPLER WAS THEN OPENED. A SMALL AMOUNT OF CHARRING WAS SEEN WITHIN THE HANDPIECE AND THE MULTIFILAMENT FIBERS WERE NOT BROKEN AT THE SAME LENGTH, INDICATING THE FIBERS BROKE WHILE THE USER WAS PULLING ON THE HANDPIECE WHILE ATTEMPTING TO FIRE IT. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
D
Patient 1
ACCORDING TO THE REPORT, "[THE COMPLAINANT] REPORTED TO ME THAT WHEN THEY PLUGGED IN THE TMR SOLOGRIP HANDPIECE, IT DID NOT HAVE ANY POWER GOING THROUGH IT WHEN THEY TEST FIRED IT. THEY PUT IT ASIDE AND USED ANOTHER HANDPIECE WHICH WORKED FINE. SHE KEPT THE UNIT IN QUESTION AND WILL RETURN WHEN WE REQUEST IT." SURGERY WAS PROLONGED.
N
Patient 1
*ADDITIONAL INFORMATION - SAMPLE EVALUATION* ONE HAND PIECE, LOT NUMBER TA ? 04095, SERIAL NUMBER (B)(4), WAS RETURNED TO CRYOLIFE. THE HOSPITAL RETURNED THE HAND PIECE IN THE CRYOLIFE-SUPPLIED RETURN KIT. UPON INITIAL INSPECTION, NO DAMAGE WAS NOTED TO THE DISTAL TIP, HANDPIECE, MONOFILAMENT AND MULTIFILAMENT FIBER SHEATHS, EXTENDER NUT CONNECTOR, OR EXTERIOR OF THE COUPLER. THE HANDPIECE WAS CONNECTED TO THE HENE LASER (MODEL 25-LHR-121-249, SERIAL NUMBER (B)(4)) TO DETECT BREAKAGE IN THE MONOFILAMENT OR MULTIFILAMENT FIBERS. THE HANDPIECE DID NOT EFFECTIVELY DELIVER LIGHT ENERGY, INDICATING A BREAKAGE SOMEWHERE IN THE FIBERS. WHILE IT IS NORMAL TO SEE A SMALL AMOUNT OF LIGHT ENERGY WITHIN THE COUPLER BETWEEN THE MONOFILAMENT AND MULTIFILAMENT FIBERS, A GREATER THAN NORMAL AMOUNT OF LIGHT ENERGY WAS SEEN INSIDE THE COUPLER. THE HANDPIECE WAS PICKED UP BY A FIELD ASSURANCE ASSOCIATE AND THE MULTIFILAMENT FIBER DISCONNECTED FROM THE COUPLER. THE COUPLER WAS THEN OPENED. A SMALL AMOUNT OF CHARRING WAS SEEN WITHIN THE HANDPIECE AND THE MULTIFILAMENT FIBERS WERE NOT BROKEN AT THE SAME LENGTH, INDICATING THE FIBERS BROKE WHILE THE USER WAS PULLING ON THE HANDPIECE WHILE ATTEMPTING TO FIRE IT. THE DEVICE HISTORY RECORD FOR LOT TA-04095 WAS REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. BASED ON THE SAMPLE EVALUATION, THE DAMAGE IS CONSISTENT WITH DAMAGE CAUSED BY A USER PULLING ON THE HANDPIECE WHILE ATTEMPTING TO FIRE IT. IF THE FIBER BECOMES BENT OR BROKEN AND THE LASER IS PULSED, EXTREME HEAT IS PRODUCED RESULTING IN CHARRING OF THE FIBERS AND SUBSEQUENT BREAKAGE OF THE FIBER BUNDLE. THE IFU PROVIDES THE FOLLOWING INSTRUCTIONS: ?EACH SOLOGRIP III HANDPIECE IS A FRAGILE SURGICAL INSTRUMENT. USE CAUTION WHEN REMOVING CONTENTS FROM PACKAGING AND DURING USE. EXCESSIVE STRESS OR TENSION ON THE OPTICAL FIBER CONTAINED IN THE HANDPIECE MAY RESULT IN DEVICE DAMAGE OR MALFUNCTION. ALWAYS PLACE THE LASER CONSOLE NEAR THE STERILE FIELD. POSITION THE WHITE FIBER COUPLER NEAR THE OPERATIVE SITE TO MINIMIZE TENSION ON THE FIBER WHEN THE HANDPIECE IS IN USE.?
D
Patient 1
ACCORDING TO THE REPORT, "[THE COMPLAINANT] REPORTED TO ME THAT WHEN THEY PLUGGED IN THE TMR SOLOGRIP HANDPIECE, IT DID NOT HAVE ANY POWER GOING THROUGH IT WHEN THEY TEST FIRED IT. THEY PUT IT ASIDE AND USED ANOTHER HANDPIECE WHICH WORKED FINE. SHE KEPT THE UNIT IN QUESTION AND WILL RETURN WHEN WE REQUEST IT." SURGERY WAS PROLONGED.