BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDOP VOLISTA®

    MDR report key: 21467580 · Received February 26, 2025

    Report

    Report Number
    9710055-2025-0000082
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 7, 2025
    Report Date
    February 26, 2025
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712401429
    PMA / PMN Number
    K130513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SPRING ARM DUST COVER (UPPER SIDE OF HORIZONTAL ARM) FELL OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHTS DID NOT MEET ITS SPECIFICATION, SINCE SPRING ARM METAL COVER DETACHMENT COULD BE CONSIDERED AS TECHNICAL DEFICIENCIES, AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICES WERE OR WERE NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ACCORDING TO SUBJECT MATTER EXPERT AT MANUFACTURER¿S, THE MOST PROBABLE ROOT CAUSES ARE : NON-CONFORMITY OF THE METAL COVERS ASSEMBLY. DEGRADATION OF THE METAL COVERS. IMPROPER USE (COLLISION WITH ANOTHER DEVICE). MAQUET SAS ANALYSIS SHOWS THAT THE METAL STRIP COMES OUT OF THE COVERS WHEN IT IS NOT CLIPPED PROPERLY. IN THE SCOPE OF OUR CONTINUOUS IMPROVEMENT POLICY, MAQUET SAS INITIATED A MODIFICATION FILE (B)(4) TO INCLUDE THIS DUST COVER FITTING PROCEDURE IN THE TECHNICAL DOCUMENTATIONS WITH ALL SPRING ARMS. 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 SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SPRING ARM DUST COVER (UPPER SIDE OF HORIZONTAL ARM) FELL OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248791 STANDOP VOLISTA® LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDVST229011A 03700712401429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown