INVUITY LIGHT RETRACTOR PHOTON GUIDE

Description of Event or Problem

THIS WAS A (B)(6) FEMALE WITH A HISTORY OF LEFT BREAST DUCTAL CARCINOMA IN SITU S/P MASTECTOMY AND RECONSTRUCTION WHO UNDERWENT A RIGHT MASTECTOMY WITH RECONSTRUCTION ON (B)(6) 2021. IN (B)(6) 2021, PATIENT NOTED PAIN ON AND OFF IN HER RIGHT BREAST BUT REPORTED IT HAD IMPROVED SPONTANEOUSLY ON A FOLLOW UP OFFICE VISIT. IN (B)(6) 2021, THE PATIENT REPORTED RECURRENT PAIN IN HER RIGHT BREAST AND IMAGING WAS ORDERED FOR FOLLOW UP. THE PATIENT COMPLETED A CT SCAN OF THE CHEST ON (B)(6) 2021, WHICH NOTED A "SMALL HYPODENSE LESION THAT APPEARS RECTANGULAR MEASURING 23 X 15 X 4 MM" THAT WAS PRESENT. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT BREAST RECONSTRUCTION REVISION AND FOREIGN BODY REMOVAL SURGERY. A SUPERIOR CAPSULOTOMY WAS PERFORMED AND A SMALL PIECE OF PLASTIC (LATER IDENTIFIED AS THE END PIECE OF THE INVUITY PHOTON GUIDE ILLUMINATOR) WAS REMOVED FROM THE RIGHT MEDIAL BREAST. RESEARCH INTO FDA MEDWATCH FOUND 5 INSTANCES OF ISSUES RELATED TO THIS DEVICE. FDA SAFETY REPORT ID# (B)(4).