inforMED
MalfunctionFSW

CV EVOLUTIONS SAPHLITE

Received Nov 10, 2008

Report 1044475-2008-00038 · MDR key 1237518

Device

Generic name

Saphlite

Manufacturer

Teleflex Medical

Model number

NA

Catalog number

89-2719

Lot number

541205

Product problems

  • Overheating of Device

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE COMPLAINT DESCRIPTION WAS REPORTED AS: LIGHT GOT HOT DURING A SAPHENOUS VEIN HARVEST. NO PT INJURY OR INTERVENTION REPORTED.

Additional Manufacturer Narrative

NO ADDITIONAL INFO AVAILABLE. DEVICE RETURNED FOR EVAL. REPORT OF EVAL AND INVESTIGATION NOT AVAILABLE AT TIME OF THIS REPORT.