GAMMAMED PLUS

Description of Event or Problem

TEMPLATE REPORTED AS NOT CLAMPING NEEDLES SECURELY. NEEDLES ARE NOT HELD FAST TO THE TEMPLATE LOCKING MECHANISM. A USER REPORTS THAT INITIALLY THEY WERE LOCKING SUFFICIENTLY, BUT AFTER HANDLING ACCORDING TO DOCUMENTATION, TWO SUBSEQUENT IMPLANTS WERE INTERRUPTED FOR RE-SCANNING BECAUSE THE NEEDLES HAD SHIFTED.

Additional Manufacturer Narrative

THERE WAS NO INJURY ASSOCIATED WITH THIS COMPLAINT. USER HAD TO ADJUST NEEDLES AND RE-SCAN RESULTING IN A MINOR TREATMENT DELAY. LARGE SHIFTS IN THE NEEDLE TEMPLATE POSITIONS WOULD BE OBVIOUS TO THE USER PRIOR TO TREATMENT. METHOD - THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS REPORTED MALFUNCTION, SHOULD IT RECUR, MAY POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.