BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL FOOT PUMP ASSEMBLY

    MDR report key: 7377625 · Received March 28, 2018

    Report

    Report Number
    3005985723-2018-00203
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 28, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: OIL LEAK FROM PISTON DEVICE EVALUATION AND RESULTS: PER GSP 164890: REPLACED PUMP ASSY PN (B)(4). PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 12/11/12 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 12-08-0042, NPR 12-08-0043, NPR 12-08-0047, NPR 12-09-0043, NPR 12-12-0012, NPR 12-08-0060. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N (B)(4)., SHOWS 2 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Additional Manufacturer Narrative · 0

    AN MDR WAS INADVERTENTLY OPENED FOR THIS MDR. PER THE CHANGES BEING MADE IN (B)(4), THIS EVENT DOES NOT MEET REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 0

    PROBLEM : OIL LEAK FROM PISTON.

    Description of Event or Problem · 0

    PROBLEM : OIL LEAK FROM PISTON.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PROBLEM : OIL LEAK FROM PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220767 SPECIAL FOOT PUMP ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization