BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDOP VOLISTA®

    MDR report key: 20745793 · Received November 21, 2024

    Report

    Report Number
    9710055-2024-0000602
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    3700712401566
    PMA / PMN Number
    K130513
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. BASED ON THE PHOTOGRAPHIC EVIDENCE THE CONNECTION BETWEEN FORK AND LIGHTHEAD IS LOOSE WITH RISK OF DETACHMENT. THERE WAS NO INJURY REPORTED, BUT WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS 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. IT IS UNKNOWN IF CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ACCORDING TO THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, THE GAP BETWEEN THE FORK AND THE LIGHTHEAD WAS CAUSED BY A LOOSENING OF THE 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 SINCE MAY 2017, THE ASSEMBLY PROCEDURE ¿GOM 5463 IND.O AND GOM5462 IND.M¿INDICATES THAT THE ORIGINAL SCREWS HAVE BEEN REPLACED BY PRE-GLUED SCREWS TO AVOID ANY LOOSENING (CHANGE REQUEST#: 160103). THIS PHENOMENON COULD OCCUR OVER A LONG PERIOD OF TIME AND IS EASY TO DETECT DURING THE PREPARATION OF OPERATING THEATRE, WHEN HANDLING THE LIGHT HEAD OR DURING YEARLY PREVENTIVE MAINTENANCE. TO PREVENT ANY SAFETY ISSUE THE USER MANUAL NU_VOLISTA_01781 MENTIONS THE DAILY CHECKS WHICH MUST BE PERFORMED BY THE USER, FOR INSTANCE CHECK THAT THE LIGHTHEAD ROTATES CORRECTLY. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO 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. BASED ON THE PHOTOGRAPHIC EVIDENCE THE CONNECTION BETWEEN FORK AND LIGHTHEAD IS LOOSE WITH RISK OF DETACHMENT. THERE WAS NO INJURY REPORTED, BUT WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459044 STANDOP VOLISTA® LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDVST229001A 3700712401566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown