FOOT TRACTION BOOT TO ORTHOVISION TABLE

Additional Manufacturer Narrative

BASED ON THE DESCRIPTION ON THE EVENT, IT APPEARS THAT THE FOOT TRACTION BOOT WAS NOT PROPERLY SECURED CAUSING THE REPORTED EVENT. AS THE DOCTOR BEGAN TO PUSH DOWN ON THE PATIENT'S FOOT THE FOOT TRACTION BOOT DETACHED FROM THE TABLE CAUSING THE DOCTOR TO LOSE HIS BALANCE AND THE PATIENT'S LEG TO LOWER IN HEIGHT. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE ORTHOVISION TABLE. WHILE ONSITE, THE TECHNICIAN FOUND THAT THE FOOT TRACTION BOOT WAS NOT ATTACHED TO THE SURGICAL TABLE. THE TECHNICIAN INSPECTED THE TABLE AND FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATION; NO REPAIRS WERE REQUIRED. A STERIS ACCOUNT MANAGER OFFERED IN-SERVICE ON THE PROPER USE AND OPERATION OF THE ORTHOVISION SURGICAL TABLE AND THE USER FACILITY HAS ACCEPTED THIS OFFER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE DOCTOR BEGAN TO PUSH DOWN ON THE FOOT TRACTION BOOT ATTACHED TO THE OTHOVISION TABLE WHEN THE BOOT CAME LOOSE CAUSING THE DOCTOR TO FALL BACKWARDS AND THE PATIENT'S LEG TO FALL FROM THE BOOT. NO INJURIES TO THE DOCTOR OR PATIENT WERE ASSOCIATED WITH THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.