TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Additional Manufacturer Narrative

AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE# (B)(4).

Description of Event or Problem

SIEMENS RECEIVED THE FOLLOWING INFORMATION (ENGLISH TRANSLATED) FROM A PATIENT WHO WAS SCANNED AT YOUR CLINICAL USING A SIEMENS ULTRASOUND SYSTEM. THIS REPORT WAS SUBMITTED THROUGH THE SIEMENS LET US KNOW REPORT PORTAL ON (B)(6) 2026: - I WAS AT A ROUTINE TRANSVAGINAL ULTRASOUND AND I HAD VERY SEVERE PAIN, WITH THE FEELING THAT MY HYSTERECTOMY SURGERY HAD BEEN DAMAGED/CRACKED. PLEASE TAKE INTO CONSIDERATION THAT IT WOULD BE GOOD FOR THE VAGINAL PROBE TO HAVE 360-DEGREE VISIBILITY BECAUSE IN MY CASE THE MOVEMENT OF THE PROBE BY THE DOCTOR CAUSED ME PAIN; I ENDED UP IN THE EMERGENCY DEPARTMENT AND UNDERWENT MRI AND CT SCANS. I CONSIDER THAT THE DEVICES COULD BE IMPROVED SO THAT BACKWARD VIEWING WOULD BE POSSIBLE. I HOPE YOU WILL INFORM DOCTORS THAT THE USE OF THE ULTRASOUND MACHINE ON PATIENTS WITH HYSTERECTOMY INVOLVES RISKS AND REQUIRES GREAT CARE, AND PERHAPS YOU COULD ADAPT THE DEVICE TO PROVIDE LATERAL AND REAR VISIBILITY FOR VIEWING THE OVARIES IN PATIENTS WITH HYSTERECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.