inforMED
MalfunctionGDF

CODMAN 36-2000 NEEDLE DRIVER

Received Apr 17, 2012 · Event occurred Apr 12, 2012

Report 2548784 · MDR key 2548784

Device

Generic name

Guide, Needle, Surgical

Manufacturer

Codman & Shurtleff

Catalog number

*

Lot number

*

Product problems

  • Detachment Of Device Component
  • Device Or Device Fragments Location Unknown

Patient

*

  • No Information

Narrative

Description of Event or Problem

GRIPPER TIP INSERT FELL OUT OF CODMAN 36-2000 NEEDLE DRIVER. AFTER SURGERY, IT WAS IDENTIFIED THAT THE GRIPPER TIP INSERT OF THE CODMAN 36-2000 NEEDLE DRIVER WAS NO LONGER ATTACHED. IT IS UNKNOWN WHERE THE TIP OF THE NEEDLE DRIVER WAS LOST.THIS NEEDLE DRIVER HAD VERY RECENTLY (WITHIN PAST TWO MONTHS) BEEN REPAIRED THE AUTHORIZED REPAIR VENDOR FOR CODMAN SURGICAL INSTRUMENTS.======================MANUFACTURER RESPONSE FOR CODMAN NEEDLE DRIVER 36-2000, CODMAN 36-2000 NEEDLE DRIVER (PER SITE REPORTER).======================ADDED TO THEIR ONGOING INVESTIGATION.