SUMMIT SWIVEL COLLIMATOR

Description of Event or Problem

SUMMIT SWIVEL COLLIMATOR MODEL # D800 CAME FREE FROM THE TUBEMOUNT, LANDING ON THE TABLE TOP, BUMPING THE HAND OF A PT. THE PT WAS RECEIVING FOLLOW UP CARE AFTER WRIST SURGERY. SUBSEQUENT X-RAYS INDICATED THAT THE SURGICAL WORK WAS UNAFFECTED BY THE INCIDENT AND THAT NO ADD'L INJURY RESULTED. THE FAILURE APPEARS TO HAVE RESULTED FROM LOOSE OR MISSING HARDWARE ON THE SWIVEL ASSEMBLY.

Additional Manufacturer Narrative

SUMMIT INDUSTRIES HAS NOT YET RECEIVED THE SUBJECT UNIT FOR EVALUATION. THE SUMMIT DEALER WAS NOTIFIED OF THE INCIDENT AND WENT TO THE USER FACILITY (UF) WHERE HE DETERMINED THAT THE COLLIMATOR SWIVEL RETAINING SCREWS HAD BECOME LOOSE AND/OR WERE MISSING WHEN THE COLLIMATOR FELL. ONE OR MORE OF THE REMAINING SCREWS HAD POSSIBLY PULLED OUT OF THE SWIVEL MOUNT ASSEMBLY, STRIPPING THE LAST TWO OF THE 8 THREADS IN THE MOUNTING ASSEMBLY. TO KEEP THE CLINIC OPERATING, HE DETERMINED THAT REPLACING THE ORIGINAL 1/4" RETAINING SCREWS WITH 1/2" ONES THAT FULLY ENGAGE THE REMAINING 6 THREADS AND ADDING LOCK-TIGHT WOULD BE ADEQUATE UNTIL A REPLACEMENT UNIT COULD ARRIVE FROM THE MFR, SUMMIT INDUSTRIES. AT THAT TIME, THE SUBJECT UNIT WILL BE RETURNED TO SUMMIT INDUSTRIES FOR EVALUATION.