SAVI SCOUT REFLECTOR MARKER
Received Sep 8, 2017 · Event occurred Aug 24, 2017
Report MW5072045 · MDR key 6851637
Device
Product problems
- Positioning Problem
Patient
67 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PT WITH ABNORMAL BREAST IMAGING, NO PALPABLE LUMP. BREAST BIOPSY WITH USE OF SAVI SCOUT EQUIPMENT. SAVI REFLECTOR MARKER IMPLANTED ONE WEEK PRIOR TO SURGERY. PRIOR TO INCISION, A PRE-TEST IDENTIFIED THE LOCATION OF THE REFLECTOR MARKER. AFTER INCISION, THE REFLECTOR MARKER WAS UNABLE TO BE DETECTED/LOCATED WITH THE HAND-PIECE. UNABLE TO LOCATE REFLECTOR MARKER WITH HAND DETECTOR, A C-ARM WITH FLUOROSCOPY WAS EMPLOYED AND SUCCESSFULLY LOCATED MARKER. BREAST BIOPSY PERFORMED. POST REMOVAL OF SPECIMEN THE SAVI REFLECTOR MARKER WAS LOCATED WITHIN THE SPECIMEN. NO HARM CAME TO PT. MFR PICKED UP REFLECTOR MARKER FROM PATHOLOGY AND RETURNED TO THEIR CORPORATE OFFICE. PLEASE CONTACT THEM REGARDING IDENTIFICATION NUMBER (S) FOR THE DEVICE.