MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAMMOMAT REVELATION; FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number	11343300
Medical Device Problem Codes	Use of Device Problem (1670); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting an investigation of the reported event.The cause of the displayed message is currently unclear.Additionally, siemens will clarify why the user struggled to remove the needle as the procedure in described in the user manual.Following the reported incident, siemens became aware of another instance of the unit not working properly.However, the needle was not inserted, and the operator was able to continue with the procedure without impact to the patient.A supplemental report will be submitted of additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Siemens was informed by its service organization about mammomat revelation malfunction that occurred during a patient examination.The biopsy needle was already inserted into the patient's breast when the system displayed a message that the procedure could not be continued.The message also indicated that the user needed to remove the needle holder.According to the operator, the needle was removed but with some difficulty.There is no injury attributed to this event.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
The two described cases were investigated extensively.The relevant log files were analyzed, and our experts attempted to reproduce the system request to unmount the needle holder in the laboratory using similar workflow.The e-box exchanged at the customer system was returned to the manufacturer for investigation as well.The described system behavior could not be reproduced.The logfiles did not show an error or any hint to the reason of the unexpected system request to remove the needle holder.This message is also displayed in case the needle holder is tried to be moved while the needle is already inserted.The described behavior is a safety mechanism to prevent movement with the needle in the breast.The e-box investigated by the supplier did not show any defect.According to information received from the customer site, no similar issues were reported since the replacement of the e-box.Since the exchanged e-box was not found to be defective, it is concluded that the problem may have been caused by a faulty electrical contact in the cabling of the e-box and that this connection problem was corrected when installing the new component.The second reported issue was related to the difficulty of releasing patient from the system following the error situation.When the inspect projection view (pv) is active during biopsy examinations, the tube arm can only be moved to 6°-position (instead of 15° position as in normal stereo pv) and it may be difficult to remove the vacuum biopsy system.To address this issue, a customer safety advisory notice xp011/20/s was released in may 2020.It is planned to introduce a change of the mammounit firmware in order to increase the moving range of the tube arm during activated inspect pv.This change is planned to be available beginning of in the third quarter of 2020 and will be released via an update instruction xp025/20/s.

• Brand Name: MAMMOMAT REVELATION
• Common Device Name: FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 9586757
• Report Number: 3004977335-2020-13104
• Device Sequence Number: 3337392
• Product Code: MUE
• UDI-Device Identifier: 04056869124575
• UDI-Public: 04056869124575
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11343300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other