BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA

    MDR report key: 7747076 · Received August 3, 2018

    Report

    Report Number
    9710055-2018-00063
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Report Date
    August 17, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    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). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT VOLISTA STANDOP DEVICE. AS STATED BY TECHNICIAN, THE PROBLEM WITH CRACKED FORK AND PAINT CHIP OCCURRED. THERE IS NO PATIENT INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. WE HAVE NO INFORMATION WHEN THE EVENT OCCURRED AND IF THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. THE CRACK APPEARS DUE TO THE DETACHMENT OF THE BONDED PARTS AND IS ONLY LOCATED ON THE OUTER COATING. THE CAUSE OF THE COATING DAMAGE CORRESPONDS TO AN EXCESSIVE GAP BETWEEN BOTH MECHANICAL PARTS REVEALED BEFORE THE COATING MANUFACTURING PROCESS. MAQUET SAS LAUNCHED THE CAPA 2015-03 AND THE DESIGN CHANGE REQUEST E160103 TO IMPROVE THE METHOD FOR ASSEMBLING THE BRACKETS REPLACING THE BONDING METHOD BY A WELDING PROCESS. THE BRACKET ASSEMBLED WITH THE WELDING PROCESS IS AVAILABLE SINCE THE BEGINNING OF 2017. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 TECHNICIAN, THE PROBLEM WITH CRACKED FORK AND PAINT CHIP OCCURRED. THERE IS NO PATIENT INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588867 VOLISTA LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568811960

    Patients

    Seq Age Sex Outcome Treatment
    1