inforMED
MalfunctionDWQ

TRIVEX SYSTEM ILLUMINATOR-HANDPIECE

Received Nov 14, 2010 · Event occurred Oct 20, 2010

Report 1913117 · MDR key 1913117

Device

Generic name

Trivex System Illuminator-handpiece

Manufacturer

Smith & Nephew

Model number

7210351

Catalog number

NA

Lot number

NA

Product problems

  • Optical Problem

Patient

42 YR

  • No Information

Narrative

Description of Event or Problem

THE LIGHT ON THE TRIVEX MACHINE WAS VERY DIM FOR THE CASE. WE CHECKED THE MACHINE, WE SWITCHED THE LIGHT CORD, THEN THE ILLUMINATOR WITH NO SUCCESS. WE SWITCHED OUT THE MACHINE TO USE THE LOANER. THERE WAS A SIGNIFICANT DIFFERENCE IN THE LIGHT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT APPLICABLE====================== MANUFACTURER RESPONSE FOR TRIVEX SYSTEM ILLUMINATOR-HANDPIECE, TRIVEX SYSTEM ILLUMINATOR-HANDPIECE======================AWAITING RESPONSE====================== MANUFACTURER RESPONSE FOR FIBER OPTIC CABLE, FIBER OPTIC CABLE======================AWAITING RESPONSE