ARM SUPPORT

Additional Manufacturer Narrative

THE ARMBOARD SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION. INVESTIGATION DETERMINED THE CAUSE OF THE OBSERVED DAMAGE TO BE ATTRIBUTED TO USER ERROR, SPECIFICALLY ALIGNING THE ORIENTATION OF THE ARMBOARD PARALLEL TO THE TABLE, CONTRARY TO THE WARNING STATEMENT INDICATED IN THE INSTRUCTIONS FOR USE. IF THE ARMBOARD IS POSITIONED PARALLEL TO THE TABLE, THIS POSITIONS THE ARMBOARD OVER THE TABLE SIDERAIL. IF THE TABLE IS POSITIONED IN CERTAIN POSITIONS THIS CAUSES THE ARMBOARD TO IMPINGE UPON THE TABLE SIDERAIL CAUSING DAMAGE TO THE TABLE AND/OR ARMBOARD. THE STERIS ACCOUNT MANAGER COUNSELED USER FACILITY PERSONNEL ON THE PROPER INSTALLATION AND USE OF THE ARMBOARD. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE ARMBOARD SUBJECT OF THE EVENT WAS REMOVED FROM SERVICE FOLLOWING THE REPORTED EVENT AND IS BEING RETURNED TO STERIS FOR EVALUATION. THE CUSTOMER PROVIDED PICTURES OF THE REPORTED ARMBOARD DAMAGE. THE PICTURES SHOWED THE ARMBOARD CARBON FIBER CONSTRUCTION WAS CRACKED AND SPLINTERED AROUND THE PIVOT BOSS. THE INSTRUCTIONS FOR USE (IFU) STATES, "TO PREVENT ARMBOARD OR TABLE DAMAGE, ENSURE ARMBOARD IS NOT INSTALLED OR MOVED PARALLEL TO TABLE SIDE RAILS. THIS ORIENTATION RESULTS IN DAMAGE TO ARMBOARD AND/OR TABLE DURING TABLE ARTICULATIONS. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE OBTAINED A SMALL CUT FROM THE SURFACE OF THEIR ARMBOARD. THE EMPLOYEE SELF-TREATED BY WASHING AND APPLICATION OF ANTISEPTIC.