inforMED
MalfunctionFHO

INSUFFLATION/ACCESS NEEDLE 14 GAUGE

Received Nov 3, 2004 · Event occurred Dec 18, 2003

Report 2647580-2004-00502 · MDR key 823036

Device

Generic name

Access Needle

Manufacturer

Ponce- Uss

Model number

NA

Catalog number

S100000

Lot number

P3J405

Product problems

  • Cut In Material

Patient

YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

REPORTEDLY, THE TOP OF THE INSUFFLATION ACCESS NEEDLE SHEARED OFF UPON INSERTION. THE SURGEON OPENED A NEW NEEDLE AND CONTINUED. NO PT INJURY WAS REPORTED. PROCEDURE: TUBAL LIGATION.