InjuryEZM
OLYMPUS
Received Jun 24, 2003 · Event occurred May 21, 2001
Report 9611174-2003-00001 · MDR key 470119
Device
Generic name
Esophageal Guide Wire
Manufacturer
Keymed (medical & Industrial Equipment) Ltd.Model number
7028717Catalog number
*
Lot number
110641
Product problems
- Detachment Of Device Component
- Tip breakage
Patient
UNKNOWN
- Dural Tear
- Surgical procedure
Narrative
Description of Event or Problem
THE PRODUCT IS A GUIDE WIRE USED DURING ENDOSCOPIC PER-ORAL DILATATION OF TUMORS IN THE ESOPHAGUS. IT HAS A FLEXIBLE COILED SPRING TIP THAT BECAME DETACHED FROM THE MAIN PORTION OF THE WIRE DURING A PROCEDURE. THE PT REQUIRED AN ESOPHAGECTOMY TO REPAIR A 2CM TEAR IN THE LOWER ESOPHAGUS.