MAUDE Adverse Event Report: NORAS MRI PRODUCTS GMBH Breast BI 7 MR Coil Set 3T; MRI Coil

Model Number	Breast BI 7 MR Coil Set 3T
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is 1 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.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.

• Brand Name: Breast BI 7 MR Coil Set 3T
• Common Device Name: MRI Coil
• Manufacturer (Section D): NORAS MRI PRODUCTS GMBH; leibnizstrasse 31; hoechberg, bavaria 97204 ; GM 97204
• Manufacturer (Section G): Noras MRI products GmbH; leibnizstrasse 4; hoechberg, bavaria 97204 ; GM 97204
• Manufacturer Contact: manuel brueckner ; leibnizstrasse 4; hoechberg, bavaria 97204 ; GM 97204
• MDR Report Key: 24964839
• Report Number: 3004929307-2026-00001
• Device Sequence Number: 10496069
• Product Code: MOS
• UDI-Device Identifier: 04251269207389
• UDI-Public: 04251269207389
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Breast BI 7 MR Coil Set 3T
• Device Catalogue Number: 118890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BD, ENCORE (MRI VACUUM BIOPSY DEVICE).; DOTAREM (CONTRAST AGENT, 11 ML).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 121 LB