MalfunctionEMH
AESCULAP PITUITARY RONGEUR
Received Mar 31, 2021 · Event occurred Feb 22, 2021
Report MW5100488 · MDR key 11602849
Device
Product problems
- Break
Patient
46 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING A L3-S1 LAMINECTOMY A PIECE OF THE 2MM PITUITARY RONGEUR BROKE OFF INSIDE THE PATIENT. SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE UNDER FLUOROSCOPY. NO HARM TO PATIENT. FDA SAFETY REPORT ID # (B)(4).