inforMED
MalfunctionFEC

USA ELITE SYSTEM OBTURATOR

Received Aug 20, 1998

Report 1519132-1998-00063 · MDR key 183974

Device

Generic name

Obturator

Manufacturer

Circon Acmi

Model number

E161

Catalog number

E161

Lot number

EW (5/93)

Product problems

  • Material Separation

Patient

NO INFO

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

PORTION OF OBTURATOR SEPARATED FROM SHEATH.

Remedial action

  • Other