inforMED
MalfunctionFHO

INSUFFLATION/ACCESS NEEDLE 14 GAUGE

Received Jun 25, 2004 · Event occurred May 19, 2004

Report 2647580-2004-00153 · MDR key 601427

Device

Generic name

Access Needle

Manufacturer

Ponce - Uss

Model number

NA

Catalog number

S100000

Lot number

UNK

Product problems

  • Tip breakage

Patient

UNKNOWN

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

REPORTEDLY, DURING THE PROCEDURE THE UPPER PART OF THE NEEDLE BROKE OFF. NO REPORTED INJURY. PROCEDURE: CHOLECYSTECTOMY