inforMED
MalfunctionFEC

USA ELITE CYS. VISUAL OBT,21F

Received Jun 26, 2001 · Event occurred Jun 4, 2001

Report 1519132-2001-00047 · MDR key 341369

Device

Generic name

500

Manufacturer

Circon Acmi

Model number

E161

Catalog number

E161

Lot number

NI

Product problems

  • Tip breakage

Patient

NO INFO

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING PROCEDURE, OBTURATOR TIP BROKE OFF BUT REMAINED IN SHEATH. THERE WAS NO PT INJURY.

Remedial action

  • Other