inforMED
OtherGEJ

SOMNUS

Received Feb 19, 2002

Report 1037007-2002-00001 · MDR key 377936

Device

Generic name

Radio Frequency Generator

Manufacturer

Gyrus Ent Llc

Model number

UNK

Catalog number

UNK

Lot number

NA

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Tissue Damage

Narrative

Description of Event or Problem

IT WAS REPORTED IN THE JOURNAL OTOLARYNGOLOGY-HEAD AND NECK SURGERY VOLUME 125, NUMBER 5, OCCULT MUCOSAL INJURIES WITH RADIOFREQUENCY ABLATION OF THE PALATE THAT THOUGH INTENDED TO BE MUCOSA-SPARING, RADIOFREQUENCY ABLATION OF THE PALATE (RFAP) IS NEVERTHELESS ASSOCIATED WITH A HIGH INCIDENCE OF MUCOSAL INJURIES, MANY OF WHICH ARE OCCULT.