InjuryDWZ

ARGON MEDICAL

Received Sep 1, 1999 · Event occurred Aug 18, 1999

Report MW1017093 · MDR key 238471

Device

Generic name

Bioptome

Manufacturer

Maxxim Medical, Inc.

Model number

190070 6FR-1.8MM

Catalog number

190070

Lot number

049907

Product problems

Design/structure problem
Difficult to Remove
Repair
Sticking

Patient

Surgery, prolonged

Narrative

Description of Event or Problem

BIOPTOME JAWS CLOSURE MECHANISM SPRUNG APART LEAVING JAWS OPEN INSIDE THE HEART. COULD NOT CLOSE WITH HANDLE. FINALLY CLOSED BY PULLING ON CORE WIRE WITH HEMOSTAT. OPEN JAWS COULD NOT BE EXTRACTED THROUGH SHEATH. THIS IS THE SECOND SUCH INSTRUMENT FAILURE IN 10 DAY PERIOD.