MalfunctionMDM
FUKUDA RETRACTOR
Received Jul 30, 2021 · Event occurred Jul 13, 2021
Report MW5102890 · MDR key 12259956
Device
Generic name
Instrument, Manual, Surgical, General Use
Product problems
- Break
Patient
51 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
CONMED FUKUDA RETRACTOR BROKE DURING SURGERY WHILE MD WAS USING IT. BOTH PIECES OF THE INSTRUMENT WERE RETRIEVED AND GIVEN TO THE OPERATING ROOM SUPERVISOR. FDA SAFETY REPORT ID # (B)(4).