AMSCO
Received May 24, 2013 · Event occurred Apr 1, 2013
Report 3131009 · MDR key 3131009
Device
Product problems
- Break
- Material Integrity Problem
Patient
*
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE STERIS 3085SP PLASTIC AC CONNECTOR THAT FITS INTO THE AC PLATE ASSEMBLY, STERIS PART # P134469339, IS HELD INTO PLACE BY VIRTUE OF 2 PLASTIC ARMS, ONE ON EITHER SIDE OF THE CONNECTOR. IN TIME, WITH THE PLUGGING IN AND UNPLUGGING OF THE AC POWER CORD INTO THE CONNECTOR, ONE OF THE PLASTIC ARMS CAN BREAK AWAY CAUSING THE AC CONNECTOR TO PIVOT LIKE A HINGE ON THE OTHER ARM. WE HAVE SEEN 3 OF THESE GO BAD OVER THE COURSE OF 5 MONTHS ON 3 DIFFERENT SURGICAL TABLES. THE CONCERN IS WITH THE DURABILITY AND THE RELIABILITY OF THE SINGLE PLASTIC ARM ON EITHER SIDE HOLDING THESE AC CONNECTORS IN PLACE. ======================MANUFACTURER RESPONSE FOR SURGICAL TABLE, STERIS SURGICAL TABLE (PER SITE REPORTER)======================THEY SAID THEY HAVE NEVER HEARD OF THIS PROBLEM BEFORE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?USE OF SURGICAL TABLEDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO