InjuryJAQ
VAGINAL APPLICATOR SET WITH CT CYLINDER
Received Jun 10, 2004 · Event occurred Mar 11, 2004
Report 9612638-2004-00001 · MDR key 529515
Device
Generic name
Remote Controlled Radionuclide Applicator System
Manufacturer
Varian Medical Systems Haan GmbhModel number
11-00414Catalog number
GM11004140
Lot number
S40
Product problems
- Device Slipped
Patient
UNKNOWN
- Erythema
Narrative
Description of Event or Problem
DURING A BRACHYTHERAPY TREATMENT A PT RECEIVED RADIATION ERYTHEMA ON BOTH INNER THIGHS. THE PROBE IN A VAGINAL CYLINDER 3.0CM APPLICATOR SLIPPED OUT OF THE APPLICATOR FOR 1/3 FRACTIONS (3 FRACTIONS AT 7GY AT 0.5CM). THE USER SITE CONCLUDED THAT THE FABRIC OF PT'S GARMENT WAS IN BETWEEN THE CLAMPING BOLT AND TANDEM CAUSING THE SLIP.