BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING ARM OF EMPOWERCTA+

    MDR report key: 7303600 · Received February 28, 2018

    Report

    Report Number
    3004753774-2018-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    January 26, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BRACCO INJENEERING SA
    Product Code
    IZQ
    PMA / PMN Number
    K071378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EMPOWERCTA+ ARTICULATING AND J-ARM BROKE AWAY AND FELL. THE OPERATOR HOLD THE SYSTEM WHEN IT FELL. THERE WAS NO PATIENT NOR OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. THE INVESTIGATION IS ONGOING. EXEMPTION NUMBER: E2018011. BRACCO DIAGNOSTICS INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF BRACCO INJENEERING S.A. (MANUFACTURER).

    Additional Manufacturer Narrative · 0

    EMPOWERCTA+ ARTICULATING AND J-ARM BROKE AWAY AND FELL. THE OPERATOR HOLD THE SYSTEM WHEN IT FELL. THERE WAS NO PATIENT NOR OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. THE INVESTIGATION SHOWS THAT THE GENERAL ASPECT OF THE ARM TENDS TO INDICATE THAT THE J-ARM HAS BEEN USED BEFORE, THAT THE SUBASSEMBLY J-ARM / TUBE HAS BEEN DAMAGED BY HOSPITAL BEFORE THE FULL BREAKAGE BUT NO PART HAS BEEN REPLACED. THE DESIGN OF THE J-ARM AS WELL AS THE MANUFACTURING CANNOT BE CONSIDERED AS THE ROOT CAUSE OF THIS FAILURE. THE PROBABLE ROOT CAUSE OF THE FAILURE IS THE CEILING MOUNT BEING USED AFTER THE EXPECTED LIFE OF THE DEVICE. THE CASE IS THEN CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 0

    EMPOWERCTA+ ARTICULATING AND J-ARM BROKE AWAY AND FELL. THE OPERATOR HOLD THE SYSTEM WHEN IT FELL. THERE WAS NO PATIENT NOR OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. THE INVESTIGATION SHOWS THAT THE GENERAL ASPECT OF THE ARM TENDS TO INDICATE THAT THE J-ARM HAS BEEN USED BEFORE, THAT THE SUB-ASSEMBLY J-ARM / TUBE HAS BEEN DAMAGED BY HOSPITAL BEFORE THE FULL BREAKAGE BUT NO PART HAS BEEN REPLACED. THE DESIGN OF THE J-ARM AS WELL AS THE MANUFACTURING CANNOT BE CONSIDERED AS THE ROOT CAUSE OF THIS FAILURE. THE PROBABLE ROOT CAUSE OF THE FAILURE IS THE CEILING MOUNT BEING USED AFTER THE EXPECTED LIFE OF THE DEVICE. THE CASE IS THEN CONSIDERED CLOSED. EXEMPTION NUMBER: E2018011. BRACCO DIAGNOSTICS INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF BRACCO INJENEERING S.A. (MANUFACTURER). - ATTACHMENT: [2018US02609_BINJ QUALITY INVESTIGATION REPORT.PDF]

    Description of Event or Problem · 0

    ON (B)(6) 2018, A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING A DEVICE MALFUNCTION WITH THE USE OF THE ARTICULATING ARM OF EMPOWERCTA+ . THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 23-FEB-2018. ON (B)(6) 2018, THE EMPOWERCTA+ ARTICULATING AND J-ARM BROKE AWAY AND FELL. THE OPERATOR HELD THE SYSTEM WHEN IT FELL. THERE WAS NO PATIENT NOR OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. A QUALITY INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A HEALTHCARE PROFESSIONAL REPORTED TO (B)(4) INJENEERING A DEVICE MALFUNCTION WITH THE USE OF THE ARTICULATING ARM OF EMPOWERCTA+ . THE REPORT WAS FORWARDED TO (B)(4) DRUG SAFETY ON 23-FEB-2018. ON (B)(6) 2018, THE EMPOWERCTA+ ARTICULATING AND J-ARM BROKE AWAY AND FELL. THE OPERATOR HELD THE SYSTEM WHEN IT FELL. THERE WAS NO PATIENT NOR OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. THE INVESTIGATION SHOWS THAT THE GENERAL ASPECT OF THE ARM TENDS TO INDICATE THAT THE J-ARM HAS BEEN USED BEFORE, THAT THE SUB-ASSEMBLY J-ARM / TUBE HAS BEEN DAMAGED BY HOSPITAL BEFORE THE FULL BREAKAGE BUT NO PART HAS BEEN REPLACED. THE DESIGN OF THE J-ARM AS WELL AS THE MANUFACTURING CANNOT BE CONSIDERED AS THE ROOT CAUSE OF THIS FAILURE. THE PROBABLE ROOT CAUSE OF THE FAILURE IS THE CEILING MOUNT BEING USED AFTER THE EXPECTED LIFE OF THE DEVICE. THE CASE IS THEN CONSIDERED CLOSED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-APR-2018: QUALITY INVESTIGATION REPORT ADDED TO THE CASE. 12-JUN-2018: CASE CORRECTED AFTER INTERNAL REVIEW BY (B)(4). (B)(4) REMOVED AS IMPORTER. IMPORTER NUMBER REMOVED FROM REPORT NUMBER PAGE. THE INVESTIGATION REPORT ATTACHMENT WAS REMOVED FROM FILE ATTACHMENTS PAGE. CORRESPONDING WORLDWIDE CASE ID PROVIDED. A NEW FORM FDA 3500A CASE WAS GENERATED. (B)(4).

    Description of Event or Problem · 0

    ON 26-JAN-2018, A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING A DEVICE MALFUNCTION WITH THE USE OF THE ARTICULATING ARM OF EMPOWERCTA+ . THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 23-FEB-2018. ON 26-JAN-2018, THE EMPOWERCTA+ ARTICULATING AND J-ARM BROKE AWAY AND FELL. THE OPERATOR HELD THE SYSTEM WHEN IT FELL. THERE WAS NO PATIENT NOR OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. THE INVESTIGATION SHOWS THAT THE GENERAL ASPECT OF THE ARM TENDS TO INDICATE THAT THE J-ARM HAS BEEN USED BEFORE, THAT THE SUB-ASSEMBLY J-ARM / TUBE HAS BEEN DAMAGED BY HOSPITAL BEFORE THE FULL BREAKAGE BUT NO PART HAS BEEN REPLACED. THE DESIGN OF THE J-ARM AS WELL AS THE MANUFACTURING CANNOT BE CONSIDERED AS THE ROOT CAUSE OF THIS FAILURE. THE PROBABLE ROOT CAUSE OF THE FAILURE IS THE CEILING MOUNT BEING USED AFTER THE EXPECTED LIFE OF THE DEVICE. THE CASE IS THEN CONSIDERED CLOSED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-APR-2018: QUALITY INVESTIGATION REPORT ADDED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146336 ARTICULATING ARM OF EMPOWERCTA+ ARTICULATING ARM OF EMPOWERCTA+ IZQ BRACCO INJENEERING SA 017416

    Patients

    Seq Age Sex Outcome Treatment
    1