INTRACAVITARY BRACHYTHERAPY APPLICATORS
Received Aug 25, 2011 · Event occurred Jul 29, 2011
Report 9612638-2011-00007 · MDR key 2258042
Device
Generic name
System, Applicator, Radionuclide, Remot
Manufacturer
Varian Medical Systems Haan GmbhProduct problems
- Inadequacy of Device Shape and/or Size
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING INSPECTION OF THE FLEXIBLE APPLICATOR PROBES, THEY OBSERVED THAT TWO ARE 2-3MM LONGER IN TOTAL LENGTH (DISTAL TIP TO WASHER, LENGTH OK) SO THAT THE TOTAL LENGTH WITH TRANSFER TUBE IS GREATER THAN 130CM. THIS HAS THE IMPLICATION THAT THE SOURCE WILL NOT REACH THE DISTAL END OF THE APPLICATOR AND THEREFORE THE DOSE IN THE PT IS 2-3MM FURTHER BACK THAN EXPECTED. NO SERIOUS INJURY TO THE PT WAS REPORTED, AS THE USER OBSERVED THIS ISSUE PRIOR TO TREATMENT. NO FURTHER PT INFO WAS PROVIDED.
Additional Manufacturer Narrative
ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RETURNED FOR EVAL. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL F/U TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.