Description of Event or Problem · 1
ON (B)(6) 2021 TWO TAGS WERE IMPLANTED INTO PATIENT'S BREAST. THE IMPLANT TEAM DID NOT HAVE A LOCALIZER READER AVAILABLE TO THEM, SO THEY WERE UNAWARE THAT THE TAG WAS NOT READABLE. THIS PRACTICE GOES AGAINST DEVICE INSTRUCTIONS AS DESCRIBED IN THE LOCALIZER LABELING. ON (B)(6) 2021 HEALTH BEACONS RECEIVED A COMPLAINT INDICATING THAT THE LOCALIZER READER UTILIZED DURING SURGERY WAS NOT READING THE RFID TAG AT ALL, NOT EVEN IN THE SPECIMEN POST-PROCEDURE. IMAGES TAKEN ON THE DAY OF THE SCHEDULED SURGERY SHOWED THAT THE TAG HAD FRACTURED INSIDE THE PATIENT'S TISSUE. THIS WAS THE REASON WHY THE TAG WAS NOT BEING READ BY THE READER. AFTER THE EXCISION SURGERY, THE TAG WAS CONFIRMED TO BE BROKEN. DESPITE MULTIPLE EFFORTS, HEALTH BEACONS WAS UNABLE TO OBTAIN INFORMATION REGARDING BREAST DENSITY OR ANY ADDITIONAL INFORMATION FROM THE IMPLANT TEAM, AS THIS IS A SEPARATE ORGANIZATION FROM THE REPORTING SITE. IT WAS CONFIRMED BY THE HOLOGIC REPRESENTATIVE THAT, EXCEPT FOR THE REPORTED EXTENDED ANESTHESIA TIME REQUIRED TO OVERCOME THE UNKNOWN BROKEN TAG DIFFICULTY, INCLUDING TRYING TO TROUBLESHOOT THE READER, THEN LOCATING THE TAG WITH IMAGING, AND THEN RECOVERING THE BROKEN TAG, THERE WERE NO OTHER IMPACTS TO THE PATIENT REPORTED. IT WAS CONFIRMED THAT THE TAG FRAGMENTS WERE SUCCESSFULLY REMOVED ON (B)(6) 2021 DURING THE SCHEDULED EXPLANT SURGERY, WITHOUT THE NEED FOR ADDITIONAL SURGICAL INTERVENTION.