MalfunctionPOZ
KIT, NEEDLE, BIOPSY
Received Oct 18, 2017 · Event occurred Aug 16, 2017
Report 6958691 · MDR key 6958691
Device
Generic name
Kit, Needle, Biopsy
Lot number
120716
Product problems
- Component Incompatible
Patient
79 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING RIGHT PARTIAL MASTECTOMY AND RIGHT SENTINAL NODE BIOPSY, THE TRU NODE WAND WOULD NOT REGISTER WITH THE TRU NODE DEVICE. NO PATIENT HARM. DEVICE SENT BACK TO MANUFACTURER FOR FOLLOW UP.