(B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR THE ABLATION PROCEDURE?- SOFT TISSUE ABLATION. WHAT WAS THE SIZE OF THE LESION?- UNKNOWN. AT WHAT DEPTH WAS THE PROBE TIP LOCATED?- UNKNOWN. WHERE WAS THE TIP OF THE TROCAR IN RELATION TO THE PROBE TIP?- UNKNOWN. WERE ANY ERROR MESSAGES DISPLAYED OR DEVICE ISSUES IDENTIFIED? PLEASE DESCRIBE.- THE TISSUE-LOC THERMOCOUPLE ON CHANNELS 1 AND 3 HAS FAILED. WHEN WAS THE BURN IDENTIFIED? AFTER THE PROCEDURE. WHAT WAS THE DEGREE OF THE SKIN BURN? UNKNOWN. DID THE PATIENT RECEIVE TREATMENT FOR THE SKIN BURN? IF YES, PLEASE DESCRIBE. YES- DEBRIDING. ARE PHOTOS OF THE BURN OR ANY IMAGING AVAILABLE? NO. WHAT IS THE CURRENT STATUS OF THE PATIENT? UNKNOWN.
D
Patient 1
IT WAS REPORTED THAT DURING A LIVER ABLATION: "I WAS NOT PRESENT FOR THE EVENT, BUT WAS RELAYED THE FOLLOWING INFORMATION. A PATIENT SUSTAINED INJURY DURING A MICROWAVE ABLATION PROCEDURE. PATIENT SUSTAINED BURN ON UMBILICUS. THE PROBE USED WAS A PR15XT AND WAS UTILIZED IN CONJUNCTION WITH A METAL TROCAR." IT IS UNKNOWN HOW THE CASE WAS COMPLETED.