BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA

    MDR report key: 8050728 · Received November 8, 2018

    Report

    Report Number
    9710055-2018-00181
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 9, 2018
    Report Date
    April 4, 2019
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF 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).

    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)(6). MAQUET SAS BECAME AWARE OF A CUSTOMER¿S PROBLEM WITH THE VOLISTA DEVICE. AS IT WAS STATED BY THE TECHNICIAN, THERE WERE CRACKS IN THE PAINT OBSERVED, SPECIFICALLY AT THE ARC OF THE FORK. THERE WAS NO INJURY TO A PATIENT REPORTED, HOWEVER IT WAS DECIDED TO REPORT THIS ISSUE BASED ON THE POTENTIAL AND IN ABUNDANCE OF CAUTION, AS ANY PARTICLE FALLING FROM THE DEVICE INTO THE STERILE FIELD MIGHT BE A SOURCE OF CONTAMINATION. WHEN REVIEWING SIMILAR REPORTABLE EVENTS REGISTERED FOR VOLISTA SURGICAL LIGHT WE WERE ABLE TO FIND SEVERAL SIMILAR ISSUES COMPARED TO THE PROBLEM INVESTIGATED HEREIN. IN NONE OF THE COMPLAINTS A SERIOUS INJURY OR DEATH OCCURRED. BASED ON THE INFORMATION COLLECTED TO DATE IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHTS DID NOT MEET THE MANUFACTURER¿S SPECIFICATION. THE MOST PROBABLE ROOT CAUSE THAT THE CRACKS APPEAR WAS THE DETACHMENT OF THE BONDED PARTS OF FORK. IT WAS ESTABLISHED THAT THE CRACKS WERE LOCATED ONLY ON THE OUTER COATING AND THERE WAS NO IMPACT TO THE INTERNAL STRUCTURE OF THE FORK ASSEMBLY. THE BREAKS ON THE COATING CORRESPOND TO THE EXCESSIVE GAP BETWEEN TWO MECHANICAL PARTS UNDER THE OUTER MATERIAL. WE HAVE NO INFORMATION REGARDING THE EXACT TIME WHEN THE DEFECT FIRST APPEARED OR IF IT WAS BEING USED FOR PATIENT TREATMENT IN THE TIME WHEN THE EVENT OCCURRED. A CORRECTIVE/PREVENTIVE ACTION INVESTIGATION INTO THE ISSUE HAS REVEALED THAT THE ISSUE MAY BE THE RESULT OF SEVERAL FACTORS, SUMMARIZED AS ISSUES WITH THE PREVIOUS UNDERSTANDING OF POST-GLUING ASPECTS. A DESIGN CHANGE IMPROVED THE ASSEMBLING METHODS FROM GLUE-BONDING TO WELDING OF THE PARTS IN PRODUCTION, SINCE BEGINNING OF 2017.

    Description of Event or Problem · 0

    ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- VOLISTA STANDOP. AS IT WAS STATED, THE CRACK ON FORK WAS FOUND AND THE PAINT CHIPPING ALSO OCCURRED. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER (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).

    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. (B)(4). EXEMPTION # E2018005. (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. (B)(4). EXEMPTION # E2018005. (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

    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
    893160 VOLISTA LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS 568811960

    Patients

    Seq Age Sex Outcome Treatment
    1