BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMAT REVELATION

    MDR report key: 14797768 · Received June 24, 2022

    Report

    Report Number
    3004977335-2022-32288
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 14, 2022
    Report Date
    February 2, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    MUE
    UDI-DI
    04056869124575
    PMA / PMN Number
    K193166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FACILITY CONTACT NAME WAS NOT PROVIDED TO SIEMENS. THE INVESTIGATION IS ONGOING. THE ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID# (B)(4).

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION WAS OBTAINED BY SIEMENS DURING THE INVESTIGATION. H10 MANUFACTURER NARRATIVE: SIEMENS HEALTHCARE INVESTIGATED THE REPORTED ISSUE IN DETAIL. IT WAS STATED BY THE CUSTOMER THAT A BIOPSY WAS PERFORMED WITH THE TUBE AT A 90° ANGLE FOR A LEFT VERTICAL APPROACH OF THE L-LM VIEW. TWO INSPECT IMAGES WERE ACQUIRED, BUT BOTH WERE BLACK. A MESSAGE WAS DISPLAYED THAT THE C-ARM SHOULD BE MOVED TO THE ZERO POSITION WITH THE CONTROL BUTTONS, EVEN THOUGH IT WAS ALREADY IN THAT POSITION. NO ERROR MESSAGE WAS DISPLAYED. BASED ON THE RECEIVED INFORMATION, THE PATIENT'S BREAST WAS COMPRESSED FOR SEVERAL MINUTES. NO INJURY WAS COMMUNICATED. THE RECEIVED LOG FILES WERE ANALYZED IN DETAIL. FROM THE ACQUISITION WORK STATION (AWS) PERSPECTIVE, THERE WAS NO ERROR. IN THE LOGS, THE MENTIONED MESSAGE FOR ROTATING THE TUBE ARM COULD BE SEEN. THIS MESSAGE IS TRIGGERED BY THE MAMMO UNIT (MU) WHICH SENDS A BLOCKING REASON FOR THE AWS WITH THE SUBJECT "WRONG ARM POSITION". THE LOG FILES SHOW THAT THE EXAMINATION STARTED AT 07:37. TARGETING WAS PERFORMED AFTER FIVE (5) SCOUT IMAGES WERE TAKEN. AT 08:11 THE OPERATOR CONFIRMED THE MOUNTED NEEDLE (EVIVA 0913-12T VERT, NOT PART OF THE SYSTEM). THE NEEDLE HOLDER STARTED MOVING AND THE SAMPLING TARGET WAS REACHED. THE NEEDLE WAS LOADED WHILE THE SWIVEL ARM WAS MOVED TO THE SIDE AND SNAPPED BACK INTO ITS ORIGINAL POSITION AT 08:16. EIGHT (8) STEREO PAIRS WERE PERFORMED IN THIS STATE. THE STEREO PAIRS SERVE TO CHECK THE NEEDLE PLACEMENT OR ARE PERFORMED IF FURTHER TARGETS ARE TO BE SET. THIS IS STATED IN THE SYSTEM OPERATOR MANUAL XPW7-340G.621.03.02, CHAPTER 2.3.5 ACQUIRING FURTHER IMAGES, PAGE 46. AFTER THE BIOPSY WAS PERFORMED, AN INSPECT EXPOSURE WAS TAKEN AT 08:37 TO CHECK THE SPECIMEN. IT WAS STATED THAT THE INSPECT IMAGES WERE BOTH BLACK. HOWEVER, THE LOG FILES INDICATE THAT THE EXPOSURE WAS PERFORMED BY THE SYSTEM WITHOUT AN ERROR MESSAGE. THE REFERENCED IMAGES WERE REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED SINCE THEY WERE NO LONGER AVAILABLE. IN GENERAL, THE DESCRIBED BEHAVIOR CAN BE CAUSED IF THE USER ATTACHES THE SPECIMEN TRAY TO THE SYSTEM ON THE WRONG SIDE OF THE ARM. THIS IS BEYOND THE CONTROL OF THE SYSTEM. THE SYSTEM INDICATES ON WHICH SIDE THE TRAY MUST BE ATTACHED. THE MENTIONED L-LM-ST PROJECTION VIEW WAS ENABLED AT 08:37 AFTER THE INSPECT IMAGES WERE TAKEN. FOR THIS, A CLIP SHOULD BE ATTACHED TO THE BIOPSIED SITE. IT WAS STATED THAT ALL BUTTONS ON EACH CONTROL PAD HAD BEEN PUSHED TO MOVE THE C-ARM OUT OF THE WAY TO BE ABLE TO PUT THE CLIP IN. BASED ON THE LOG FILES, THE L-LM-ST EXPOSURE WAS ALREADY AT THE 23RD EXPOSURE. THIS IS AN UNUSUALLY HIGH NUMBER FOR AN EXAMINATION. THE MU CHECKED THE EXPOSURE DATA AND FOUND AN INVALID POSITION FOR THIS EXPOSURE. THIS WAS ANALYZED BY THE SOFTWARE EXPERTS. IT WAS FOUND THAT THE MU DID NOT MOVE WITH THE BIOPSY TABLE INSERTED AS THE ARM ROTATION WAS NO LONGER IN THE VALID RANGE OF -91.00°; 91.00°. THEREFORE, THE MU SIGNALED WITH THE BLOCKED REASON "ARMSTEREOTOMOPOS". SINCE THE COMPRESSION WAS ALSO GREATER THAN 15N, THE ROTATION OF THE TUBE COULD NOT BE CARRIED OUT. IN BIOPSY MODE, MOVEMENT IS ONLY POSSIBLE IF THE COMPRESSION IS <15N THIS IS STATED IN THE SYSTEM OPERATOR MANUAL XPW7-340G.621.03.02.02, CHAPTER 1.1.7 SAFETY MECHANISM, PAGE 15). IN SUCH A CASE, THE SAFETY CONCEPT ENSURES THAT FURTHER MOVEMENTS ARE BLOCKED IF THE SYSTEM IS OUTSIDE THE VALID VALUE RANGE, OR THE COMPRESSION IS GREATER THAN 15N. IN THIS SITUATION, MOVEMENTS ARE ALSO BLOCKED IF THE ARM MUST BE MOVED OUT OF THE HOLDER TO REMOVE THE HOLDER. AS A RESULT, THE DESIRED CLIP CANNOT BE SET IN THIS STATE. BASED ON THE LOG FILES, THE L-LM-ST PROJECTION VIEW WAS DISABLED AT 08.42. THE COMPRESSION WAS RELEASED ON 08:46 TO UNBLOCK THE SYSTEM. WITH THIS, SYSTEM MOVEMENTS WERE AGAIN POSSIBLE WITHOUT ANY RESTRICTIONS. THE BREAST WAS COMPRESSED AGAIN, AND ANOTHER STEREO PAIR WAS SUCCESSFULLY PERFORMED. THE EXAMINATION WAS FINISHED AT 09:08. IN THE PRESENT CASE, THE DECISIVE FACTOR FOR THE ERROR STATE WAS THAT AN UNUSUALLY LARGE NUMBER OF STEREO EXPOSURES WERE MADE AFTER THE NEEDLE WAS SET. SINCE THE SYSTEM COULD NOT MOVE TO DEFINED ANGLES IN BETWEEN EXPOSURES, THE SYSTEM COULD MANEUVER ITSELF INTO AN INVALID RANGE. THIS BEHAVIOR IS OBSERVED BY THE PRODUCT STEERING GROUP AND WILL BE CONSIDERED FOR FUTURE SOFTWARE VERSIONS. CURRENTLY, NO UPDATE IS PLANNED AS THE PROBABILITY OF OCCURRENCE IS CONSIDERED LOW. THE PROBLEM OCCURRED DUE TO AN UNUSUAL WORKFLOW. ACCORDING TO THE RECEIVED INFORMATION, THE DESCRIBED ISSUE COULD NOT BE REPRODUCED. H11 CORRECTED DATA: D8: THE DEVICE WAS NOT SERVICED BY A THIRD PARTY AND SHOULD HAVE BEEN CHECKED "NO" IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JUNE 24, 2022. G2: REPORT SOURCE "COMPANY REPRESENTATIVE" SHOULD NOT HAVE BEEN CHECKED SINCE SIEMENS HEALTHCARE HAD NOT COMPLETED THE INVESTIGATION OF THE REPORTED ISSUE. H8: USAGE OF DEVICE WAS INCORRECTLY CHECKED AS "REUSE" IN THE INITIAL REPORT. THIS FIELD SHOULD HAVE BEEN BLANK.

    Description of Event or Problem · 0

    DURING A BIOPSY PROCEDURE THE USER HAD PROBLEMS REMOVING THE NEEDLE FROM THE PATIENT'S BREAST AND RELEASING THE PATIENT FROM THE MAMMOMAT REVELATION SYSTEM IN A TIMELY MANNER. THE SWIVEL ARM COULD NOT BE ROTATED AS INTENDED. AFTER DECOMPRESSING THE PATIENT'S BREAST, MOVEMENT WAS ENABLED AGAIN. NO OTHER INJURY THAN THE PROBLEMS WITH RELEASE WAS REPORTED. THE ISSUE WILL BE CLASSIFIED AS REPORTABLE WITH AN ABUNDANCE OF CAUTION IN CONSIDERATION TO A WORST-CASE SCENARIO AND THE RESPECTIVE PSYCHOLOGICAL EFFECTS ON THE PATIENT IF RELEASE TAKES A SIGNIFICANT TIME EVEN THOUGH THE RESPECTIVE INJURY WOULD BE CLASSIFIED AS MODERATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION/EVENT CLARIFICATION IT WAS STATED BY THE CUSTOMER THAT A BIOPSY WAS PERFORMED WITH THE TUBE AT A 90° ANGLE FOR A LEFT VERTICAL APPROACH OF THE L-LM VIEW. TWO INSPECT IMAGES WERE ACQUIRED, BUT BOTH WERE BLACK. A MESSAGE WAS DISPLAYED THAT THE C-ARM SHOULD BE MOVED TO THE ZERO POSITION WITH THE CONTROL BUTTONS, EVEN THOUGH IT WAS ALREADY IN THAT POSITION. NO ERROR MESSAGE WAS DISPLAYED. BASED ON THE RECEIVED INFORMATION, THE PATIENT'S BREAST WAS COMPRESSED FOR SEVERAL MINUTES. NO OTHER INJURY ASIDE FROM THE PROBLEMS WITH THE RELEASE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761595 MAMMOMAT REVELATION FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC MUE SIEMENS HEALTHCARE GMBH 11343300 04056869124575

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown