OtherGDF

ATEC INTRODUCER LOCALIZATION SET SURESIGHT

Received Apr 30, 2012 · Event occurred Apr 3, 2012

Report 3003862400-2012-00006 · MDR key 2564073

Device

Generic name

21 Cfr 878.4800

Manufacturer

Hologic, Inc.

Model number

ILS 0914-20OB

Lot number

202042

Product problems

Break
Fracture

Patient

Not reported

No Code Available

Narrative

Description of Event or Problem

THE ATEC INTRODUCER LOCALIZATION SET SURESIGHT OBTURATOR BROKE WHEN THE PT UNEXPECTEDLY AND FORCEFULLY PULLED OUT OF THE COMPRESSION GRID. DEVICE FRACTURED AND PARTIALLY REMAINED IN THE BREAST. THE DEVICE, AND ALL PIECES, WERE EASILY REMOVED WITHOUT FURTHER INCIDENT. PT WAS NOT HARMED.