SCANLAN BULLDOG CLAMP

Description of Event or Problem

THE REPORTED EVENT WAS THAT DURING A DA VINCI-ASSISTED RIGHT PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT HAD A LOT OF BLEEDING. THE PROCEDURE WAS ABORTED AND CONVERTED TO OPEN SURGERY. DURING THE PROCEDURE, A THIRD-PARTY GOLD SCANLAN BULLDOG CLAMP WAS USED VIA A SEPARATE PORT. THE USE OF THE SCANLAN BULLDOG CLAMP WAS A REQUIRED STEP FOR THE PROCEDURE, THIS WAS USED TO CLAMP THE RENAL ARTERY. THE SURGEON REPORTED THAT THE SCANLAN BULLDOG CLAMP DID NOT HAVE A STRONG GRIP TO CLAMP THE PATIENT'S STIFF RENAL ARTERY, WHICH CAUSED A LOT OF BLEEDING. THE BLEEDING COULD NOT BE CONTROLLED, AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT WAS REPORTED TO BE STABLE AND REMAINS HOSPITALIZED. THE SURGEON REPORTED THAT THERE WAS NOT AN ISSUE WITH THE DA VINCI SINGLE PORT SYSTEM, BUT RATHER, WITH THIRD-PARTY INSTRUMENTATION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).