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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Event or Problem Description
This is an initial 30-day report.This report is one of five related reports concerning local skin injuries reported in association with breast biopsy procedures performed using a noras breast bi 7 biopsy coil, serial number (b)(6).The manufacturer's investigation has been completed, and the final investigation results are included in this initial report.The manufacturer was informed of this event as part of a cluster of five alleged local skin injuries occurring during the period from (b)(6) 2025 through (b)(6) 2026.No individual clinical questionnaire, photographs, procedure date, patient age, patient weight, detailed description of the injury, treatment information, or patient outcome information were made available for this specific patient.Therefore, the circumstances and clinical severity of this individual event could not be independently confirmed.The manufacturer completed its investigation of this event and the four related reports.The investigation included review of the available customer information, clinical information available for the related cases, imaging and system data, device history, service information, quality assurance testing, rf-related testing, and an external review of the clinical workflow.The investigation did not identify a reproducible device malfunction or rf-heating mechanism attributable to the breast bi 7 biopsy coil.Testing of the returned device showed that it met the applicable quality assurance requirements.Additional testing performed in accordance with nema ms 14 demonstrated maximum measured temperatures of 34.2 °c and 34.5 °c without a localized hotspot.Based on the available information and completed testing, a product-related thermal mechanism is considered unlikely.The exact cause of the reported skin injury could not be conclusively determined.Possible contributing factors associated with the local biopsy setup, including contact conditions, accessory materials, moisture, pressure, and the specific procedural configuration, could not be excluded.The device was replaced, and no comparable events were subsequently reported by the customer.
Additional Manufacturer Narrative
Submission history: an initial submission for this event was transmitted to fda on 23-apr-2026.The fda acknowledgements indicated that the report failed because the manufacturer report number 3004929307-2026-00003 had inadvertently been used.That report number had already been assigned to another patient report within the same event cluster.Consequently, the attempted submission for this patient was rejected as a duplicate and was not accepted as a valid mdr.The error was identified during a subsequent reconciliation of the fda acknowledgements while preparing the completed investigation reports.The manufacturer is reviewing its emdr report-number assignment and acknowledgement-review process to reduce the risk of recurrence.Final investigation update: the manufacturer completed its investigation of the five related reports concerning local skin injuries reported in connection with breast biopsy procedures performed using breast bi 7 biopsy coil serial number (b)(6).No patient-specific clinical questionnaire, photographs, procedure date, detailed injury information, treatment information, or patient outcome information were available for this individual report.Consequently, the clinical circumstances and severity of this specific event could not be independently confirmed.The overall investigation included review of the available clinical information for the related cases, imaging and system data, device history and service records, quality assurance testing of the returned device, additional rf-related testing, and an external assessment of the clinical workflow.The returned device met the applicable quality assurance requirements.Additional testing performed in accordance with nema ms 14 demonstrated maximum measured temperatures of 34.2 degrees c and 34.5 degrees c without a localized hotspot.No reproducible device malfunction or rf-heating mechanism attributable to the biopsy coil was identified.Based on the completed investigation, a product-related thermal mechanism is considered unlikely.The exact cause of the alleged injury could not be conclusively determined.Possible contributing factors associated with the local biopsy setup, including contact conditions, accessory materials, moisture, pressure, and the specific procedural configuration, could not be excluded.The device was replaced, and no comparable events were subsequently reported by the customer.The manufacturer considers the investigation complete.This initial report contains the final investigation results.Additional follow-up information will be submitted if relevant new information becomes available.

• Brand Name: Breast BI 7 MR Coil Set 3T
• Common Device Name: MRI Coil
• Manufacturer (Section D): Noras MRI products GmbH; leibnizstrasse 4; 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: 50437731
• Report Number: 3004929307-2026-00005
• Device Sequence Number: 13158940
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female