SUGITA
Received Feb 7, 2012 · Event occurred Oct 19, 2011
Report 2466843 · MDR key 2466843
Device
Generic name
Retractor, Neurosurgical
Manufacturer
Mizuho America Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
73 YR
- No Information
Narrative
Description of Event or Problem
A SMALL PIECE OF THE SUGITA RETRACTOR BROKE (A HOOK) DURING SURGERY WHILE THE DR WAS PLACING NEAR THE SURGICAL INCISION. BOTH PIECES WERE RETRIEVED AND HANDED OFF THE FIELD. X-RAY OF PATIENT'S HEAD WAS DONE BEFORE CLOSURE TO ENSURE THAT NO PIECES WERE LEFT BEHIND. READ NEGATIVE.