Description of Event or Problem · 0
THE PROBLEM WAS REPORTED TO US VIA CUSTOMER COMPLAINT (B)(4) ON (B)(6) 2023: WHEN USING THE MORCELLATOR, THE CUTTING MODULE CONTINUED TO ROTATE EVEN THOUGH THE ACTIVATION SWITCH OF THE HANDLE MODULE WAS RELEASED BY THE USER. THE UB-20230501_MORCELLATOR_SCHALTER INVESTIGATION REPORT WAS PREPARED TO ANALYZE THE CAUSE.THE CAUSE OF THE ERROR PATTERN WAS FOUND TO BE A FAULTY SWITCH FUNCTION, I.E. THE CONTACT DISTANCES OF THE SWITCH MAY BE TOO SMALL. THE SEAT OF THE FIXING SCREW OF THE ACTIVATION SWITCH IN THE GRIP MODULE WAS TESTED WITH AN UNSUITABLE TESTING DEVICE. AS A RESULT, PRODUCTS WITH TOO SMALL A SWITCH CONTACT DISTANCE (CONTACT SCREW TO SPRING PLATE) HAVE COME INTO CIRCULATION. WITH THESE PRODUCTS, IT IS THEREFORE POSSIBLE THAT THE GRIP MODULE TRANSMITS AN "ON" SIGNAL TO THE CONTROL UNIT EVEN AFTER THE ACTIVATION SWITCH HAS BEEN RELEASED AND THAT THE CUTTING MODULE CONTINUES TO ROTATE EVEN AFTER THE ACTIVATION SWITCH HAS BEEN RELEASED.REASON FOR FSCA: URGENT SAFETY INFORMATION IS BEING ISSUED TO REDUCE THE RISK OF THE OCCURRENCE OF A SIGNIFICANT DELAY IN THE MEDICAL PROCEDURE IF A USER HAS TO MAKE AN UNPLANNED CHANGE FROM HAND TO FOOT CONTROL DURING A PROCEDURE DUE TO THE SUDDEN PROBLEM DESCRIBED.TO DATE, WE HAVE NOT RECEIVED ANY REPORTS OF PATIENT HARM RESULTING FROM THE ISSUE DESCRIBED. AFTER TESTING AND EVALUATION OF THE PRODUCT, THE INTERNAL VIGILANCE PROCEDURE STARTED AT THE BEGINNING OF JUNE.