inforMED
MalfunctionFHO

INSUFFLATION/ACCESS NEEDLE 14G

Received Sep 20, 2002 · Event occurred Aug 20, 2002

Report 2647580-2002-00196 · MDR key 418460

Device

Generic name

Surgical Access Needle

Manufacturer

Ponce - Uss

Model number

NA

Catalog number

S100000

Lot number

P2E127

Product problems

  • Break
  • Difficult to Insert

Patient

UNKNOWN

  • Foreign body, removal of

Narrative

Description of Event or Problem

PROCEDURE: LAPAROSCOPY (NON-SPECIFIC). REPORTEDLY, THE SURGEON INSERTED THE NEEDLE AND THE NEEDLE BROKE AT THE WHITE PLASTIC AREA (HUB). THE SURGEON LOCATED AND REMOVED THE NEEDLE FROM THE CAVITY. NO INJURY REPORTED.