BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA STANDOP

    MDR report key: 8433903 · Received March 19, 2019

    Report

    Report Number
    9710055-2019-00093
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 26, 2019
    Report Date
    April 9, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH A SURGICAL LIGHT VOLISTA DEVICE. AS IT WAS STATED, RUST OCCURRED ON THE DIFFERENT PARTS OF VOLISTA DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLE FALLING INTO THE STERILE FIELD MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT MAY NOT HAVE MET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. RUSTED SURFACE IS INDICATED BY OUR PRODUCT EXPERTS TO LIKELY BE CAUSED BY AN INFLUENCE OF CHEMICAL DETERGENTS USED FOR CLEANING, OR, POTENTIALLY AN ISSUE IN THE PAINT PREPARATION PROCESS WITH A PREVIOUS SUPPLIER. DUE TO THE LIMITED INFORMATION RECEIVED FROM THE CUSTOMER, DESPITE OUR BEST EFFORTS, WE WERE NOT ABLE TO IDENTIFY THE DEVICE AND THEREFORE COULD NOT CHECK THE SUPPLIER FOR THIS PAINTED SUB-ASSEMBLY. WE BELIEVE THAT IF THE MAINTENANCE AND CARE INSTRUCTIONS AT THE CUSTOMER WOULD HAVE BEEN FOLLOWED THE INCIDENT LIKELY COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. 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).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER 2019-62780.

    Description of Event or Problem · 0

    ON (B)(6) 2019 MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- VOLISTA. AS IT WAS STATED, THE RUST OCCURRED ON THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLE FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. IT WAS ESTABLISHED THAT FOLLOWING PARTS WITH SERIAL AND REFERENCE NUMBERS ARE AFFECTED BY THIS ISSUE, UNDER THE REPORTED CONFIGURATION: (SERIAL #/REFERENCE #) (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228101 VOLISTA STANDOP LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567910990;ARD568811963;ARD515053999;ARD60041061

    Patients

    Seq Age Sex Outcome Treatment
    1