MalfunctionFSW

STRYKER

Received Apr 19, 2006 · Event occurred Apr 7, 2006

Report 709918 · MDR key 709918

Device

Generic name

Light Source

Manufacturer

Stryker Endoscopy

Model number

X7000

Catalog number

Lot number

Product problems

Repair
Defective Component

Patient

Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

FIBEROPTIC LIGHT SOURCE FAILED DURING SHOULDER ARTHROSCOPY PROCEDURE. SURGEON WAS UNABLE TO SEE SURGICAL SITE. A DEFECTIVE FIBEROPTIC CABLE WAS REPLACED BY BIOMED, RESOLVING THE PROBLEM. THE CASE RESUMED AND WAS COMPLETED.WE HAVE HAD NUMEROUS IDENTICAL FAILURES WITH THIS MODEL LIGHT SOURCE/LIGHT CABLE.