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	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is 2 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.
Event or Problem Description
This is follow-up report 1 and the final investigation update for manufacturer report 3004929307-2026-00002.This report is one of five related reports concerning local skin injuries associated with breast biopsy procedures performed at the same user facility using the same breast bi 7 mr coil, serial number (b)(6).The event occurred on (b)(6)2026.The patient was a 56-year-old female, 160 cm in height and weighing 65 kg.The reported skin lesion was located on the left breast above the nipple and measured approximately 6 cm by 2 cm.Blistering was observed within 24 hours, followed by ulceration.A lumpectomy was performed five days after the biopsy.The available records do not establish whether the lumpectomy was part of the treatment of the skin lesion.The procedure was performed in the prone, feet-first position with the arms in the superman position.The left breast was biopsied.No contact with the inner wall of the mr bore and no skin-to-skin contact were reported.The patient did not report a sensation of heat during the procedure.The manufacturer's investigation has been completed.The investigation did not establish a device-related root cause.The final evaluation is provided in sections b6 and h11.
Additional Manufacturer Narrative
Final investigation update: the manufacturer completed its investigation of the five related reports involving local skin injuries after mr-guided left breast biopsy procedures performed at the same user facility with breast bi 7 coil serial number (b)(6).The actual returned device was evaluated.The investigation included coil quality-assurance testing, rf laboratory testing, simulation of potential detuning and protection-circuit faults, mr testing under simulated fault conditions, rf field comparisons, nema ms 14 heating testing, review of available clinical and imaging information, and testing of the breast bi 7 coil in combination with the spine 32 rs coil used at the customer site.The returned coil passed the complete coil quality-assurance test on may 12, 2026.Testing under simulated electrical fault conditions did not produce a reproducible localized heating mechanism.During nema ms 14 testing, the actual returned coil was exposed for 2.5 hours in both connected and unconnected configurations at rf exposure levels above the specified target.Corrected maximum surface temperatures remained more than 5 degrees c below the applicable limit, and no localized thermal hotspot was identified.Rf field testing did not identify an abnormal field pattern caused by the breast bi 7 coil or an abnormal interaction with the customer's spine 32 rs coil.A later receive-channel deviation was determined to result from a trimmer damaged during intentionally intensified performance testing.The trimmer was repaired.Because the coil had passed the complete quality-assurance evaluation before this intensified testing, this test-induced condition was not considered evidence of a device condition present during the clinical events.The investigation did not identify a reproducible rf heating mechanism attributable to the breast bi 7 coil.A device-related thermal mechanism is considered unlikely based on the available evidence.However, the specific cause of the reported skin injuries could not be conclusively established because the original biopsy setup, contact materials, compresses, moisture conditions and exact contact geometry were not preserved.A local interaction involving patient anatomy, superficial lesion location, contact geometry, material, moisture or pressure remains a possible but unconfirmed hypothesis.The affected coil was replaced and will be retained.No further comparable events have been reported with the replacement coil.If a comparable event recurs, the manufacturer plans an immediate on-site assessment of the clinical workflow and preservation of the relevant mr data and setup information.The manufacturer considers the present investigation complete and this report to be the final follow-up report.

• 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: 24964862
• Report Number: 3004929307-2026-00002
• Device Sequence Number: 21423513
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 143 LB