MalfunctionFHO

STEP REPOSABLE INSUFFLATION & ACCESS NEEDLE, 14G

Received Jul 9, 2001 · Event occurred Jun 12, 2001

Report 2647580-2001-00374 · MDR key 342078

Device

Generic name

Surgical Access Device

Manufacturer

United States Surgical Corporation

Model number

Catalog number

RS100000

Lot number

P1C621

Product problems

Detachment Of Device Component
Tip breakage

Patient

UNKNOWN

Foreign body, removal of
Surgical procedure, additional

Narrative

Description of Event or Problem

REPORTEDLY, THE TIP OF THE INSUFFLATION NEEDLE BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE TIP WAS RETRIEVED LAPAROSCOPICALLY. NO PATIENT INJURY REPORTED.