EPISEALER PATELLOFEMORAL SYSTEM

Description of Event or Problem

EPISURF MEDICAL INC'S PRESIDENT (B)(6) RECEIVED INFORMATION OF THE EVENT ON THE 16TH OF OCTOBER 2025, FROM THE SURGEON SCHEDULED TO PERFORM THE SURGERY, DR. (B)(6), AT THE USER FACILITY (B)(6) OUTPATIENT SURGERY, (B)(6), UNITED STATES. THE SURGEON INFORMED EPISURF MEDICAL INC OF THE EVENT AS DESCRIBED BELOW AND CONCLUDED THAT THE EVENT WAS SOLELY DUE TO THAT THERE HAD BEEN MISCOMMUNICATION BETWEEN THE SURGEON AND THE MR TECHNICIAN ON WHICH KNEE (LEFT OR RIGHT) TO BE SCANNED AND FOR WHICH KNEE (LEFT OR RIGHT) TO ORDER AN IMPLANT FOR. THE PATIENT HAD BILATERAL DAMAGE TO BOTH LEFT AND RIGHT KNEE. IT WAS AGREED UPON BETWEEN THE SURGEON AND PATIENT THAT THE RIGHT KNEE WAS TO BE OPERATED ON, BUT MR IMAGES TAKEN AT THE HEALTH CARE FACILITY WERE ONLY OF THE LEFT KNEE. EPISURF RECEIVED MR IMAGES OF A LEFT KNEE UPLOADED BY THE HEALTH CARE FACILITY TO EPISURF'S ORDER MANAGEMENT SYSTEM. DESIGN OF THE DEVICE WAS MADE BASED ON THESE MR IMAGES OF THE LEFT KNEE, IN ACCORDANCE WITH ROUTINE PROCEDURE, AND THE SURGEON APPROVED THE DESIGN AND ORDER ON (B)(6) 2025 WHERE IT WAS SPECIFIED THAT THE DESIGN WAS SPECIFICALLY FOR THE PATIENT'S LEFT KNEE. THE PRODUCT WAS THEN RELEASED TO MARKET BY EPISURF AND SHIPPED TO THE HEALTHCARE FACILITY IN ACCORDANCE WITH ROUTINE PROCEDURE. WHEN IT WAS TIME FOR SURGERY, (B)(6) 2025, THE SURGEON MADE AN INCISION TO THE RIGHT KNEE AND EXPOSED THE JOINT, AS AGREED UPON BY THE PATIENT AND SURGEON. THE SURGEON REALIZED THAT THE DEVICE (INTENDED FOR THE LEFT KNEE) DID NOT FIT THE RIGHT KNEE JOINT. THE SURGEON THEN REALIZED THAT THE DEVICE ORDERED WAS INTENDED FOR THE PATIENT'S LEFT KNEE. THE EPISURF DEVICE WAS NOT ATTACHED OR USED ON THE PATIENT. ALL LABELLING AND ORDER INFORMATION SPECIFIED THAT THE DEVICES WERE INTENDED FOR A LEFT KNEE. THE SURGEON CLOSED THE INCISION OF THE PATIENT AND ENDED THE SURGERY WITHOUT PERFORMING THE INTENDED PROCEDURE. EPISURF MEDICAL INC HAS RECEIVED INFORMATION THAT THE PATIENT IS IN RECOVERY (CORRESPONDING TO NORMAL RECOVERY AFTER A SURGERY WHERE AN INCISION HAS BEEN PERFORMED UNDER ANESTHESIA) WITH NO OTHER DAMAGE TO A BODY STRUCTURE, THAN THE SCAR AFTER CLOSING THE INCISION.