BREAST BI 7 MR COIL SET 3T

Description of Event or Problem

THIS REPORT IS 3 OF 5 REPORTS ASSOCIATED WITH THE SAME DEVICE MODEL AND USER FACILITY. ON MARCH 24, 2026, THE MANUFACTURER WAS INFORMED OF A CLUSTER OF INCIDENTS. THE CUSTOMER ALLEGED THAT UP TO 5 PATIENTS SUSTAINED SUPERFICIAL BURNS DURING BREAST BIOPSY PROCEDURES BETWEEN (B)(6) 2025 AND (B)(6) 2026. THE EXAMINATIONS WERE PERFORMED USING THE NORAS BREAST BI 7 COIL (SN (B)(6)) IN CONJUNCTION WITH A SIEMENS MAGNETOM VIDA MRI SCANNER. TO DATE, THE USER FACILITY HAS NOT PROVIDED A CLINICAL QUESTIONNAIRE OR ANY SPECIFIC PATIENT DETAILS FOR THIS ALLEGED EVENT. PRELIMINARY QUALITY ASSURANCE (QA) CHECKS AND MR TESTING OF THE INVOLVED COIL (SN (B)(6)) CONDUCTED BY THE SYSTEM INTEGRATOR DID NOT REVEAL ANY FAULTS OR MALFUNCTIONS. HOWEVER, COMPREHENSIVE LABORATORY TESTING AND TECHNICAL EVALUATION BY THE LEGAL MANUFACTURER ARE STILL PENDING. THE ROOT CAUSE OF THE REPORTED BURNS REMAINS UNCONFIRMED. WE ARE ACTIVELY REVIEWING THE AVAILABLE CLINICAL DATA TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE EVENT. AN UPDATED FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.