inforMED
MalfunctionFEC

ROTATING C/F VISUAL OBTURATOR

Received Jun 6, 2002 · Event occurred May 7, 2002

Report 1519132-2002-00045 · MDR key 398794

Device

Generic name

Fec

Manufacturer

Acmi Norwalk

Model number

ERVO-CF25

Catalog number

ERVO-CF25

Lot number

*

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Burn(s)

Narrative

Description of Event or Problem

CUSTOMER WANTS PRODUCT CHECK TO MAKE SURE PRODUCT IS WITHIN SPECS. PATIENT ABLATION BURN, NO PERMANENT INJURY TO PATIENT.