IT WAS REPORTED THAT ON (B)(6) 2012, TWO PATIENTS WERE TREATED ON A MOBILE LITHOSTAR MODULARIS UNIT AT TWO DIFFERENT FACILITIES BY DIFFERENT OPERATING TECHNICIANS. THE FIRST PATIENT, A (B)(6) FEMALE, WAS TREATED AT 9 AM FOR A STONE IN HER RIGHT DISTAL UTERUS. THIS PATIENT RECEIVED 4,000 SHOCKS, AT 60 SHOCKS PER MINUTE, AT MAXIMUM POWER LEVEL 6. THE PROCEDURE LASTED FOR ALMOST AN HOUR AND HALF BUT APPROXIMATELY 1 CM STONE DID NOT APPEAR TO CHANGE. THREE DAYS AFTER THE PROCEDURE THE PATIENT WAS DIAGNOSED WITH A RUPTURED SPLEEN. THE SPLEEN HAD TO BE REMOVED. THE SECOND PATIENT WAS TREATED FOR A STONE IN THE LEFT UTERERO-PELVIC JUNCTION. THE PATIENT WAS INJECTED WITH CONTRAST AND A STENT WAS PLACED. THE PATIENT RECEIVED 3500 SHOCKS, AT 60 SHOCKS PER MINUTE, AT MAXIMUM POWER LEVEL 3.2. AFTER THE PROCEDURE THE PATIENT DEVELOPED A LEFT SUBCAPSULAR HEMATOMA. THE PATIENT RECEIVED BLOOD TRANSFUSION SEVERAL DAYS LATER.
N
Patient 1
SIEMENS LOCAL SERVICE ENGINEER, (B)(4), CHECKED THE SYSTEM. THE ENGINEER PERFORMED A PRESSURE TEST ON THE SHOCK HEAD AND IT WAS WITHIN TOLERANCE. NO CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND THE DEVICE COULD BE FOUND. OVER 3000 PATIENTS WERE TREATED ON THIS SYSTEM WITHOUT ANY REPORTED INCIDENTS. THE CUSTOMER STATED THAT THE INJURIES WERE NOT RELATED TO THE SYSTEM FUNCTION AND CONTINUES TO USE THE UNIT. THE REPORTED ISSUES HAVE NOT REOCCURRED. THE INVESTIGATION IS ON-GOING.