| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | X8000 LIGHTSOURCE | LIGHT, SURGICAL, FLOOR STANDING | STRYKER ENDOSCOPY-SAN JOSE | FSS | 0220200000 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-01-31 | 0 |
Patient 1
IT WAS REPORTED THAT DURING SURGERY USING AN X8000 LIGHTSOURCE WITH A FIBEROPTIC CABLE THE CAMERA HEAD OVERHEATED AND HAS BURNED THE PATIENT'S LEG. THE STERILE AREA HAS BEEN DAMAGED DUE TO BURNINGS, AS WELL. DURING THE SECOND SURGERY, THE DOCTOR REPLACED THE FIBEROPTIC CABLE BY ANOTHER NEW ONE AND THE SAME ISSUE HAS OCCURRED.
Patient 1
THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE PRODUCT WAS SUBJECTED TO A SHAKE TEST TO LOCATE LOOSE COMPONENTS; THERE WERE NONE. INITIAL POWER SEQUENCE INCLUDED: POWERING UP; CONFIRMING DISPLAY ACTIVITY; LOADING CORRECT SOFTWARE; STANDBY MODE CHECK; BULB IGNITION; ERROR CODE CHECK; REPEATING SEQUENCE SEVERAL TIMES. ALL POWER SEQUENCE TESTS REPEATEDLY PASSED WITH NO ERROR CODES BEING POSTED. FUNCTIONALITY TESTING INCLUDED: STANDBY/RUN MODE CYCLING; VARIABILITY OF LIGHT INTENSITY; LIGHTCABLE/SCOPE DISCONNECT; LIGHTCABLE/JAW INTERACTION; DOOR/BULB IGNITION CYCLING; FRONT PANEL CONTROLS. ALL FUNCTIONALITY TESTS PASSED, HOWEVER, THE CABLE/JAW ENGAGEMENT FAILED. MEASUREMENTS WERE TAKEN ON THE BULB, VOLTAGE, AND LUMEN OUTPUT; ALL WITHIN SPECIFICATION EXCEPT THE BULB HAD OVER THE RECOMMENDED USAGE HOURS. DURING THE INTERNAL INSPECTION THE HOT MIRROR FILTER WAS BROKEN DUE TO LONG USAGE; THIS CAUSED THE UNIT TO PRODUCE EXCESSIVE HEAT VIA THE LIGHT CABLE. THIS ALSO CAUSED THE LIGHT OUTPUT TO REMAIN ON AFTER THE CABLE WAS REMOVED. ADDITIONALLY, THE XENON BULB TEMPERATURE WAS WITHIN SPECIFICATION AND MONITORED BY AN INTERNAL THERMAL SENSOR THAT WOULD SHUT OFF THE LIGHT SOURCE IF AN OVER TEMPERATURE CONDITION OCCURRED; IN THIS CASE THERE WAS NOT A BULB OVER TEMPERATURE. HOWEVER, A SECONDARY THERMAL PROTECTION IS THE HOT MIRROR. THE HOT MIRROR BLOCKS THE HOT INFRARED LIGHT WHILE ALLOWING THE VISIBLE LIGHT TO PASS FROM THE LIGHT PORT VIA THE LIGHT CABLE; THE LIGHT CABLE HAS NO INFLUENCE ON THE LIGHT TEMPERATURE. IF THE HOT MIRROR IS MISSING OR BROKEN, THEN EXCESSIVE HEAT CAN TRANSMIT THROUGH THE LIGHT CABLE TO THE DISTAL END ADAPTER THAT ATTACHES TO THE CAMERA HEAD; THAT AREA WOULD THEN BE PRONE TO EXCESSIVE HEAT. A SAFETY MECHANISM IS BUILT INTO THE LIGHT SOURCE THAT CAUSES THE UNIT TO EMIT LIGHT ONCE THE CABLE IS REMOVED. WHEN THAT CONDITION OCCURS, THE UNIT SHOULD BE TAKEN OUT OF USAGE. THE PROBABLE ROOT CAUSE IS LONG USAGE FAILURE OF THE HOT MIRROR FILTER. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.