BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA

    MDR report key: 7796857 · Received August 20, 2018

    Report

    Report Number
    9710055-2018-00073
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Date of Event
    July 23, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, (B)(4). EXEMPTION#: E2018005. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(6). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT VOLISTA STANDOP DEVICE. IT WAS STATED THE HANDLE FELL OFF BEFORE THE SURGERY. THERE WAS NO ADVERSE OUTCOME REPORTED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT-HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE. THE ROOT CAUSE ANALYSIS CONFIRMED THAT THE MALFUNCTION OF THE CENTRAL SUPPORT CAN OCCUR AS A RESULTS OF TWO FACTORS: EXCESSIVE TIGHTENING OF SCREWS DURING MOUNTING OF THE HANDLE SUPPORT DURING INSTALLATION OR WHEN THE HANDLE IS REMOVED AND REINSTALLED AT THE CUSTOMER SITE. FROM THE INFORMATION THAT WAS POSSIBLE TO BE OBTAINED WE CANNOT CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. TO PREVENT ANY OTHER SIMILAR INCIDENT WE HAVE ADDRESSED THIS ISSUE WITH A FIELD ACTION MSA-2017-006-IU IN US MARKET.

    Description of Event or Problem · 0

    ON (B)(6) 2018 MAQUET (B)(4) BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- VOLISTA. AS STATED BY CUSTOMER, LIGHT HANDLE FELL OFF THE LIGHT HEAD. THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT BE A SOURCE OF CONTAMINATION. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637455 VOLISTA LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568811963

    Patients

    Seq Age Sex Outcome Treatment
    1