CERVIX APPLICATOR SET WITH CT-CYLINDERS
Received May 20, 2011 · Event occurred Apr 20, 2011
Report 9612638-2011-00003 · MDR key 2111097
Device
Generic name
System, Applicator, Radionuclide, R-c
Manufacturer
Varian Medical Systems Haan GmbhCatalog number
GM11002540
Lot number
G22
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT A WELD BROKE ON THE TANDEM. THE BROKEN WELD WAS DISCOVERED AFTER A TREATMENT AND THE TANDEM WAS DISCONTINUED CLINICALLY AND VARIAN NOTIFIED. THE WELD (ADHESIVE BOND) WAS REPORTED TO BE BROKEN AT THE TREATMENT END OF THE TANDEM DEVICE, AT THE DIAMETER SIZE TRANSITION. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE APPLICATOR PROBE HAS BEEN SENT TO (B)(4) FOR INVESTIGATION AND ANALYSIS. A REPLACEMENT WAS ORDERED FOR THE CUSTOMER. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.