inforMED
BWN

SKYTRON

Received Aug 17, 2012

Report 1825014-2012-00008 · MDR key 2715768

Device

Generic name

Tri-clamp

Manufacturer

Amatech Corp

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Break
  • Detachment Of Device Component
  • Component Falling

Patient

*

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IN RESPONSE TO (B)(6), SKYTRON CONTACTED OUR DISTRIBUTOR IN THE AREA, (B)(4), WHO SENT THEIR TERRITORY MANAGER TO THE FACILITY. HE COULD NOT MAKE A DETERMINATION AS TO THE CAUSE OF THE TRI-CLAMP FAILURE AND WILL SEND THE CLAMP TO SKYTRON FOR EVAL. WHEN THAT EVAL HAS BEEN COMPLETED, WE WILL SEND THE FDA ADD'L INFO. THE FACILITY ONLY USES THIS ATTACHMENT FOR ONE SURGEON AND ONE PROCEDURE TYPE. THEY HAVE DECIDED TO UTILIZE STIRRUPS INSTEAD OF THE SPLIT LEG WITH THE TRI-CLAMP AT THIS TIME.