SCANLAN VASCU-STATT PLUS

Additional Manufacturer Narrative

OUR INITAL INVESTIGATION REVIEWED PRODUCT STOCK, AND MANUFACTURING RECORDS NO NON-CONFORMITIES IDENTIFED IN THESE RECORDS. THE RISK FILE WAS REVIEWED. THE PRODUCT WAS RECEIVED FOR EVALUATION ON 2/6/26. VISUAL INSPECTION OF THE CLAMP WAS PERFORMED. THE CLAMP IS WITHIN SPECIFICATION. NO NON-CONFORMITIES WERE IDENTIFIED. AS THE DEVICE IS INTENDED FOR GENERAL SURGICAL USE, VASCULATURE WITH ANATOMICAL VARIABILITY RESULTANT OF THE DISEASE STATE OR OCCURRING CONGENITALLY MAY BE SELECTED FOR OCCLUSION AT THE DISCRETION OF THE PROFESSIONAL USER. SUCH VARIATION MAY RESULT IN REDUCED SUITABILITY OR EFFICACY OF THE DEVICE WHEN APPLIED TO THE VESSEL; HOWEVER, NO SYSTEMIC PATTERN OF THIS OCCURRENCE HAS BEEN IDENTIFIED. ROOT CAUSE ANALYSIS NO NONCONFORMITIES WERE NOTED. UNABLE TO ASCERTAIN THE ROOT CAUSE OF THIS REPORTED ISSUE WITH THE AVAILABLE INFORMATION.

Description of Event or Problem

SCANLAN WAS CONTACTED REGARDING A VASCU STAT PLUS NOT FULLY FUNCTIONING. THE END USER STATED ON 01/09/2026, THERE WAS A PROBLEM WITH THE VASCU STAT PLUS 1 X 1001-572 (LOT #: 8204001). THE HOSPITAL REPORTED THAT DURING THE CASE THE BULLDOG CLAMP DIDN'T CLOSE FULLY ON THE TIP. THEY HAD TO USE ANOTHER BULLDOG CLAMP. IT WORKED WITHOUT ANY PROBLEM AND THERE WAS NO HARM TO THE PATIENT. SINCE THEORETICALLY A NOT FULLY CLOSED BULLDOG CAN LEAD TO A PATIENT PROBLEM, THE HOSPITAL DECIDED TO REPORT THIS EVENT AS A VIGILANCE CASE TO SWISS MEDIC. ADDITIONAL INFORMATION RECEIVED 1/14/2026 THE SURGEON WAS APPLYING THE CLAMP TO THE INTERNAL MAMMARY ARTERY, AND WHEN THE SURGEON RECOGNIZED BLEEDING ON THE CLAMP SIDE, HE USED A NEW CLAMP WITHOUT ANY ISSUE. HE STATED THAT THE CLAMPING PRESSURE WAS NOT ENOUGH TO PROPERLY OCCLUDE THE VESSEL. THE TIPS OF THE FOAM CLAMP JAWS WERE MORE OPEN, AND THE CLAMP JAWS DID NOT FULLY CLOSE AND OCCLUDE THE VESSEL.