BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA ACCESS

    MDR report key: 19190023 · Received April 26, 2024

    Report

    Report Number
    9710055-2024-00299
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Report Date
    April 26, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712401351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER WAS GETINGE TECHNICIAN. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 VERSION OR MODEL #: ARD568805906. CORRECTED D4 VERSION OR MODEL #: ARDVCS209007A. PREVIOUS D4 CATALOG #: ARD568805906. CORRECTED D4 CATALOG #: BLANK PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: (B)(6), PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS H4 MANUFACTURE DATE: 2020-02-04. CORRECTED H4 MANUFACTURE DATE: 2020-02-06 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 600. DURING MAINTENANCE IT WAS FOUND THAT DUST COVER (PART CATALOG NUMBER: HM56053311) FROM SPRING ARM WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS 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. CLAIMED DEVICE WAS 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 (E131106) 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 23RD APRIL, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA ACCESS 600. DURING MAINTENANCE IT WAS FOUND THAT DUST COVER (PART CATALOG NUMBER: HM56053311) FROM SPRING ARM WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865979 VOLISTA ACCESS LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDVCS209007A 03700712401351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown