N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 5401177
- MDR report key
- 5401177
- Report number
- 1063481-2016-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-12-29
- Date received
- 2016-02-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROCHELLE MANEY
- Address
- 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US
- Phone
- 770-770-7704
- 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 | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE | CRYOLIFE, INC. | MNO | HP-SG3 | TA-04049 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-02-01 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORT, "#1 - LASER FIBER WAS SEPERATED FROM CENTER CONNECTION."
N
Patient 1
ACCORDING TO THE REPORT, "#1 - LASER FIBER WAS SEPARATED FROM CENTER CONNECTION." AN EMAIL WAS SENT ASKING IF THE HANDPIECE HAD BEEN USED, IF TMR HAD BEEN PERFORMED, AND IF THERE WAS ANY IMPACT TO THE PATIENT. A RESPONSE WAS RECEIVED STATING THAT THE STAFF HAD THE ISSUE WITH THE HANDPIECE DURING SET UP FOR THE LASER PORTION OF THE CASE, CAUSING A DELAY. ANOTHER HANDPIECE WAS OPENED AND WORKED PROPERLY. A SAMPLE REVIEW WAS CONDUCTED AND THE RETURNED HANDPIECE WAS VISUALLY INSPECTED. TA-04049-35 HAD THE SINGLE FIBER PULLED OUT FROM THE COUPLER. IT APPEARED AS THOUGH THE CLADDING HAD NOT BEEN REMOVED TO A SUFFICIENT POINT IN ORDER FOR THE SINGLE FIBER TO SEAT INTO THE ADHESIVE INSIDE THE COUPLER. THE ADHESIVE WAS PRESENT INSIDE THE COUPLER AND A DARK MARK (BURN MARK) WAS VISIBLE ON THE SINGLE FIBER. THE THUMB SLIDE MECHANISM ON THE HANDPIECE WAS FUNCTIONAL AND THE FIBERS RETRACTED WITHOUT A PROBLEM. FURTHER EVALUATION WAS PERFORMED AND MEASUREMENTS WERE TAKEN USING CALIPERS TO DETERMINE IF THE CLADDING HAD BEEN REMOVED TO A SUFFICIENT POINT IN ORDER FOR THE SINGLE FIBER TO SEAT INTO THE ADHESIVE INSIDE THE COUPLER. THESE MEASUREMENTS MET RELEASE SPECIFICATIONS. THE MANUFACTURING RECORDS FOR LOT TA-04049-35 WAS REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL RELEASE SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE ROOT CAUSE COULD NOT BE DETERMINED. 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, "#1 - LASER FIBER WAS SEPERATED FROM CENTER CONNECTION."