| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SOLARGEN 2100S CONSOLE | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE | CRYOLIFE, INC. | MNO | SG-2100S | VSS01 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-09 | 0 |
Patient 1
ACCORDING TO THE REPORT FROM THE FIELD TECHNICIAN, "LASER DID NOT RECOGNIZE FOOT PEDAL. CUSTOMER WAS ABLE TO JIGGLE WIRE AND HAVE LASER RECOGNIZE THE FOOT PEDAL." ADDITIONAL INFORMATION INDICATED THAT IT WAS NOT BEING USED DURING A PROCEDURE AT THE TIME OF THE INCIDENT.
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Patient 1
ACCORDING TO THE REPORT FROM THE FIELD TECHNICIAN, "LASER DID NOT RECOGNIZE FOOT PEDAL. CUSTOMER WAS ABLE TO JIGGLE WIRE AND HAVE LASER RECOGNIZE THE FOOT PEDAL." ADDITIONAL INFORMATION INDICATED THAT IT WAS NOT BEING USED DURING A PROCEDURE AT THE TIME OF THE INCIDENT. A SAMPLE EVALUATION WAS HELD ON 06/25/2015. THE SOLARGEN CONSOLE FOOTSWITCH ((B)(4), LOT VSS01), POWER CORD, AND POWER CORD CONNECTOR WERE VISUALLY INSPECTED. FOOTSWITCH FUNCTIONALITY WAS TESTED BY CONNECTING IT TO A TEST CONSOLE. NO EXTERNAL VISIBLE DAMAGE WAS NOTED ON THE FOOT SWITCH, POWER CORD, OR THE POWER CORD CONNECTOR. INITIALLY, THE TEST CONSOLE WAS ABLE TO RECOGNIZE THE FOOT SWITCH WHEN CONNECTED. THE FOOT SWITCH WAS ABLE TO ENGAGE AND CONTROL THE TEST FIBER. THE POWER CORD WAS THEN MANUALLY MANIPULATED AT THE POINT OF CONTACT WITH THE FOOT SWITCH, BUT THIS DID NOT AFFECT ITS ABILITY TO FUNCTION. HOWEVER, WHEN THE POWER CORD WAS MANIPULATED AT THE INSERTION POINT ON THE CONSOLE, THE CONSOLE READ "FOOT SWITCH NOT INSTALLED." ADDITIONAL INFORMATION WAS RECEIVED FROM THE TECHNICIANS ON 06/26/2015. THEY INSPECTED THE FOOT PEDAL FURTHER AND DISASSEMBLED THE CONNECTOR THAT PLUGS INTO THE LASER, FINDING THAT THE INTEGRITY OF THE FOOT PEDAL GROUNDING HAD BEEN COMPROMISED. THIS WOULD CAUSE THE INTERMITTENT FUNCTIONING OF THE CONSOLE WHEN CONNECTED TO THE FOOT SWITCH. THE SOLARGEN CONSOLE AND ITS ASSOCIATED FOOTSWITCH ARE MOBILE RENTAL UNITS WITH A HIGH FREQUENCY OF USE. IT IS LIKELY THAT BECAUSE OF THE REPEATED USE, PLUGGING AND UNPLUGGING OF THE FOOTSWITCH CONNECTOR, DAMAGE WAS INCURRED. MANUFACTURING AND QUALITY DATA IS UNAVAILABLE FOR THE FOOT SWITCH SHIPPED AS A COMPONENT OF SOLARGEN CONSOLE (B)(4) LOT VSS01. THE DEVICE HISTORY RECORD OF LOT VSS01, PROVIDED BY NEW STAR LASERS DOES NOT INCLUDE THE LOT NUMBER OF THE FOOTSWITCH INCLUDED IN THE SHIPMENT AND TESTING OF THE FOOTSWITCH CANNOT BE CONFIRMED. ADDITIONALLY, FUNCTIONAL TESTING OF THE CONSOLE AT CRYOLIFE WITH THE INCLUDED COMPONENTS HAD NOT YET BEEN IMPLEMENTED AS A PART OF THE INCOMING INSPECTION OF LASER CONSOLES. THE TECHNICIANS INSPECTED THE RETURNED FOOT PEDAL AND IT WAS DISCOVERED THAT THE INTEGRITY OF THE FOOT PEDAL CONNECTOR HAD BEEN COMPROMISED WITH A BROKEN GROUND WIRE. THIS WOULD CAUSE THE INTERMITTENT FUNCTIONING OF THE CONSOLE WHEN CONNECTED TO THE LASER. AN ACTIVE REVIEW OF THE SERVICE HISTORY STARTING ON (B)(6) 2012 THRU (B)(6) 2015 SHOWED NO PREVIOUS ISSUES OR COMPLAINTS IN REGARDS TO THE FOOT PEDAL AND THE OBSERVED ERROR CODE, "FOOT SWITCH NOT INSTALLED." THE GROUNDING INTEGRITY OF THE LASER FOOT PEDAL WAS COMPROMISED BY A BROKEN WIRE IN THE LOCKING CONNECTOR THAT ATTACHES TO THE BACK PANEL ON THE LASER, LABELED FOR THE FOOT PEDAL. A REPLACEMENT FOOT PEDAL SP2227 WAS SHIPPED TO THE CUSTOMER.
Patient 1
ACCORDING TO THE REPORT FROM THE FIELD TECHNICIAN, "LASER DID NOT RECOGNIZE FOOT PEDAL. CUSTOMER WAS ABLE TO JIGGLE WIRE AND HAVE LASER RECOGNIZE THE FOOT PEDAL." ADDITIONAL INFORMATION INDICATED THAT IT WAS NOT BEING USED DURING A PROCEDURE AT THE TIME OF THE INCIDENT.