2080 IA SURGICAL TABLE

Description of Event or Problem

PT WAS POSITIONED FOR SHOULDER SCOPE ON OPERATING ROOM TABLE - ARM OF TABLE BROKE. TWO STEEL PINS BROKE IN HALF. PT WAS NOT INJURED.

Additional Manufacturer Narrative

NO INJURY TO THE PT DUE TO THE EVENT. (B)(4). STERIS DOES NOT OFFER THE OLD STYLE PIN BECAUSE THERE IS NORMALLY DAMAGE TO THE TAPER PIN HOLES IN THE LEVER ARM ASSEMBLY AND THE TAPER PINS WILL NOT STAY SECURELY IN THE HOLES. THE CUSTOMER WAS TOLD TO ORDER AND REPLACE THE ENTIRE BACK SECTION LEVEL ARM ASSEMBLY, PN P055114-001, WHICH COMES WITH THE NEW TAPER STYLE PINS. THE CUSTOMER HAD GOTTEN THE PRIOR PINS FOR REPAIRING THE TABLE, FROM A 3RD PARTY (B)(4). AT FIRST THEY WERE UNDER THE ASSUMPTION THAT THEY HAD GOTTEN THE PART FROM US AND WERE CONCERNED AS TO WHY WE WOULD STILL STOCK A PART THAT HAS BEEN UPDATED BY ANOTHER. THE TECH ASKED THEM TO PRODUCE A SHIPPING RECEIPT TO CONFIRM THE ORIGIN OF THE PARTS. EVIDENTLY THEY THOUGHT THAT SINCE THE PARTS ARRIVED IN A "STERIS" BOX THAT THEY CAME FROM US. THE TECH ALSO DID AN INVESTIGATION AND CONTACTED DISPATCH TO ENSURE THAT THE OLD PINS COULD NOT BE ORDERED. THEY HAVE ORDERED THE BACK SUPPORT REPLACEMENT KIT TO INSTALL IN THE PLACE OF THEIR PREVIOUS REPAIR. THE TECH CONFIRMED ON 4/18/2006, THAT THE CUSTOMER REPORTED TO HIM THAT THEY HAD COMPLETED THE REPAIRS. ADD'L INFO FROM UF REPORT: REPORT DATE: 03/23/2006. BRAND NAME: AMSCO SURGICAL TABLE. COMMON DEVICE NAME: O.R. TABLE. MODEL: 2080MIA.