BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA 600 SF STANDOP

    MDR report key: 7221208 · Received January 26, 2018

    Report

    Report Number
    9710055-2018-00004
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 3, 2018
    Report Date
    May 11, 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. (B)(4). CONTACT PERSON: (B)(6). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT VOLISTA STANDOP DEVICE. AS IT WAS STATED, THE RACKET WHICH IS USED TO CONNECT THE LIGHT HEAD AND FORK BROKE AND LIGHT HEAD WAS HANGING FROM CABLES. THE ISSUE OCCURRED DURING THE PRE-OPERATIVE STAGE WITH PATIENT IN OPERATION THEATER. THERE IS NO INJURY REPORTED. WE REPORTED THIS ISSUE IN ABUNDANCE OF CAUTION, AS ANY FALLING OBJECT 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. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE OCCURRENCE RATE FOR THE ISSUE OF THE LIGHT HEAD SHAFT BREAKING IS LOW (TOTAL OF 3 COMPLAINTS IN THE LAST 5 YEARS OF DAILY USE OF A LARGE NUMBER OF SIMILAR DEVICES). THE INVESTIGATION WAS PERFORMED BY MAQUET SAS. IT WAS NOTICED DURING TECHNICAL INVESTIGATION THAT THERE WAS NO VISIBLE USE MARKS AT THE LOCATION OF ONE OF THREE SCREWS. IT WAS ESTABLISHED THAT ONE SCREW HAS BEEN FORGOTTEN DURING ASSEMBLING OF THE LIGHT AT MAQUET SAS. THE CONTROL PROCESS OF THESE LIGHT HEADS HAS BEEN MODIFIED SINCE JANUARY, 2016. THE PRESENCE OF 3 SCREWS WITH GLUE IS NOW REQUIRED IN THE INSPECTION REPORT (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- VOLISTA STANDOP. AS IT WAS STATED, THE RACKET BROKE AND LIGHT HEAD WAS HANGING FROM CABLES. THE ISSUE OCCURRED DURING THE PRE-OPERATIVE WITH PATIENT IN OPERATION THEATRE. THERE IS NO INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65260 VOLISTA 600 SF STANDOP LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1