BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTICARE PLATINUM

    MDR report key: 1705217 · Received May 27, 2010

    Report

    Report Number
    1220984-2010-00003
    Event Type
    Injury
    Date Received
    May 27, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 26, 2010
    Manufacturer
    HOLOGIC, INC
    Product Code
    IZH
    PMA / PMN Number
    K030666
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD ENGINEER RELEASED THE STOP SWITCH ON THE BACK OF THE SYSTEM. HE THEN OBSERVED THE TUBE HEAD ARM DRIVE IN THE UPWARD POSITION. HE MANUALLY POWERED OFF THE SYSTEM AD CHECKED THE SWITCHES ON THE TABLE CONTROL ASSEMBLY. HE CHECKED RELAY FROM THE POWER CONTROL PC BOARD FOR THE UP SWITCH TUBE MOTION AND FOOTSWITCHES, THEY ALL APPEARED TO BE OPERATING NORMALLY, EXCEPT THE UP SWITCH FOR THE TUBE DRIVE ON THE TABLE CONTROL ASSEMBLY. THERE WAS NOT AS MUCH SPRING BACK AFTER PUSHING THAT SWITCH, AS WITH OTHER SWITCHES ON THE BOARD. THE FIELD ENGINEER POWERED ON THE SYSTEM WITH THE TUBE ARM DOWN OFF THE STOP SWITCHES AND COULD NOT REPRODUCE THE ISSUE AFTER TRYING FOR 2 HOURS. THE FIELD ENGINEER REPLACED THE FOLLOWING COMPONENTS: BREAST TRAY SHIELD (DAMAGED BY THE PRY-BAR); POWER CONTROL PC BOARD; TABLE CONTROL PC BOARD AND FOOTSWITCHES. THE SYSTEM WAS TURNED OVER TO THE SITE AFTER IT WAS TESTED AND CONFIRMED TO BE FUNCTIONING AS INTENDED. RESULTS: THE TABLE CONTROL PC BOARD WAS DETERMINED TO HAVE A COMPROMISED SWITCH. THE SWITCH WAS ABLE TO INTERMITTENTLY CLOSE ELECTRICALLY WITH A MINIMAL LIGHT TOUCH WITH LESS THAN 1N FORCE. THE OTHER RETURNED PC BOARD AND FOOTSWITCHES FUNCTIONED NORMALLY. THE COMPROMISED SWITCH ON THE TABLE CONTROL PC BOARD MAY HAVE CONTRIBUTED TO THIS EVENT, BUT NO SPECIFIC CONCLUSION COULD BE DETERMINED BASED ON THE INFORMATION PROVIDED AND THE EVALUATION CONDUCTED.

    Description of Event or Problem · 1

    THE TECHNOLOGIST WAS CLEANING THE STEREO-TACTIC BREAST BIOPSY SYSTEM FOLLOWING A BIOPSY PROCEDURE. WHEN SHE MOVED THE STAGE DOWN TO WIPE, THE STAGE SUDDENLY MOVED UP CATCHING HER RIGHT HAND AT THE KNUCKLES BETWEEN THE BREAST PLATE AND THE TABLETOP. SHE TRIED TO REMOVE HER HAND, BUT HER HAND WAS STUCK. HER FINGERS WERE FINALLY REMOVED WITH THE USE OF A PRY-BAR AND ULTRA SOUND GEL. THE TECHNOLOGIST RECEIVED IMMEDIATE TREATMENT IN A HOSPITAL EMERGENCY ROOM. THE TECHNOLOGIST STATED THAT SHE WAS "OKAY, NO BROKEN BONES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY SYSTEM IZH HOLOGIC, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other