inforMED
MalfunctionFCI

EVIVA

Received Nov 17, 2014 · Event occurred Nov 12, 2014

Report 4260928 · MDR key 4260928

Device

Generic name

Biopsy Punch

Manufacturer

Hologic, Inc.

Model number

*

Catalog number

EVIVA 0913-20

Lot number

14G04RB

Product problems

  • Failure to Fire

Patient

71 YR

  • No Patient Involvement

Narrative

Description of Event or Problem

DURING PRE-CHECK ON THE BIOPSY PROBE, IT FAILED TO FIRE AGAIN AFTER FIRST CHECK. BUTTON USE TO SET PROBE TO PRE-FIRE AGAIN FAILED AFTER FIRST CHECK. ALL THIS WAS FOUND PRIOR TO USE ON THE PT.