BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA

    MDR report key: 23777339 · Received December 11, 2025

    Report

    Report Number
    9710055-2025-0000310
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 11, 2025
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712420659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE SURGICAL LIGHTS - VOLISTA ACCESS II. IT WAS REPORTED THAT THE KEYPADS FELL OFF DURING SURGERY. THE FAULT DID NOT CAUSE ANY PATIENT HARM OR DELAYS IN INTERVENTIONAL PROCEDURES. HOWEVER, WE DECIDED TO REPORT THE ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY COMPONENT FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE MAY CAUSE CONTAMINATION OR INJURY. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. ROOT CAUSE ANALYSIS WAS PERFORMED BY A SUBJECT MATTER EXPERT AT THE MANUFACTURER¿S, THE VOLISTA ACCESS II HEADLIGHT¿S KEYPAD FOIL DETACHED AND DROPPED. THE ROOT CAUSE OF THE FRONT PANEL DETACHMENT IN THE CAPACITIVE KEYBOARD TO THE PCB LIES IN THE ADHESIVE CHOICE IMPLEMENTED DURING THE PRODUCT DESIGN STAGE. A DESIGN CHANGE (ECR-241203) HAS BEEN INITIATED IN ORDER TO IMPROVE THE KEYPAD ADHERENCE TO THE PCB. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE SURGICAL LIGHTS - VOLISTA ACCESS II. IT WAS REPORTED THAT THE KEYPADS FELL OFF DURING SURGERY. THE FAULT DID NOT CAUSE ANY PATIENT HARM OR DELAYS IN INTERVENTIONAL PROCEDURES. HOWEVER, WE DECIDED TO REPORT THE ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS ANY COMPONENT FALLING INTO THE STERILE FIELD OR DURING A PROCEDURE MAY CAUSE CONTAMINATION OR INJURY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553983 VOLISTA LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDVCS209032A 03700712420659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown