BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA STANDOP

    MDR report key: 10792431 · Received November 5, 2020

    Report

    Report Number
    9710055-2020-00462
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    March 8, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ VOLISTA STANDOP. AS IT WAS STATED CUSTOMER COMPLAINED ABOUT LIGHT HEAD OF THE DEVICE. SERVICE TECHNICIAN WHO ARRIVED ON SITE NOTICED IMPROPER MOVEMENT OF THE LIGHTHEAD ON THE FORK WHICH WAS CAUSED BY LOOSENING OF THE SCREWS. NO INFORMATION ABOUT ANY INJURY WAS PROVIDED IN THE CASE AT HAND, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AND BASED ON POTENTIAL AS LOOSENING OF THE SCREWS ON THE FORK COULD LED TO DETACHMENT OF THE LIGHTHEAD AND THIS FURTHER COULD LED TO SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION SINCE A SCREWS WERE LOOSENED, AND IT CONTRIBUTED TO THE REPORTED SITUATION. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE, WE HAVE BEEN ABLE TO FIND SEVERAL SIMILAR FAULT DESCRIPTIONS COMPARED TO THE SITUATION INVESTIGATED HERE, IN NONE A SERIOUS INJURY OR WORSE OCCURRED. THE GAP BETWEEN THE FORK AND THE LIGHTHEAD WAS CAUSED BY A LOOSENING OF THE BRACKET FIXING SCREWS OVER A LONG PERIOD OF TIME. SINCE MAY 2017, THE ASSEMBLY PROCEDURE ¿GOM 5463 IND.O AND GOM5462 IND.M¿ INDICATES THAT THE ORIGINAL SCREWS HAVE BEEN REPLACED BY PRE-GLUED SCREWS. TO PREVENT ANY SAFETY ISSUE THE USER MANUAL MENTIONS TO CHECK THE LIGHTHEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE AND TO PERFORM YEARLY PREVENTIVE MAINTENANCE. GETINGE 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

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 2ND OF NOVEMBER 2020 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ VOLISTA STANDOP. THE RECEIVED CUSTOMER ALLEGATION WAS POINTING TO THE ISSUE WITH LIGHTHEAD OF THE DEVICE. GETINGE SERVICE TECHNICIAN, WHO ARRIVED ON SITE, NOTICED IMPROPER MOVEMENT OF THE LIGHTHEAD ON THE FORK WHICH WAS CAUSED BY LOOSENING OF THE SCREWS. NO INFORMATION ABOUT ANY INJURY WAS PROVIDED IN THE CASE AT HAND, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AND BASED ON POTENTIAL AS LOOSENING OF THE SCREWS ON THE FORK COULD LED TO DETACHMENT OF THE LIGHTHEAD AND THIS FURTHER COULD LED TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260276 VOLISTA STANDOP LAMP, SURGICAL FTD MAQUET SAS ARD568812960

    Patients

    Seq Age Sex Outcome Treatment
    1