DEROYAL

Description of Event or Problem

THE HOSPITAL REPORTED EXCESS BLEEDING OCCURRED DURING USE OF THE CIRCUMCISION CLAMP.

Additional Manufacturer Narrative

DESCRIBE EVENT OR PROBLEM: THE HOSPITAL REPORTED EXCESS BLEEDING OCCURRED DURING USE OF THE CIRCUMCISION CLAMP. DEROYAL: THE SUPPLIER'S INVESTIGATION DETERMINED THAT LOTS WERE BUILT OUT OF SPECIFICATION, RESULTING IN THE POTENTIAL FOR THE DEVICE TO NOT CLAMP THE SURGICAL SITE PROPERLY. DEROYAL HAD MADE A ONE TIME PURCHASE FROM G.A. SURGICAL AND HAS DETERMINED TO CONDUCT A VOLUNTARY RECALL OF ALL PRODUCT PURCHASED FROM THEM. ANY PRODUCT REMAINING IN INVENTORY HAS BEEN QUARANTINED FOR DESTRUCTION, AND INITIAL RECALL LETTERS HAVE BEEN SENT TO AFFECTED CUSTOMERS.