BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLISTA STANDOP 400 / 600

    MDR report key: 16407262 · Received February 21, 2023

    Report

    Report Number
    9710055-2023-00112
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Report Date
    February 21, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - THE CONFIGURATION OF TWO HEADLIGHTS VOLISTA STANDOP 400 AND 600. IT WAS STATED THE HEADLIGHT TO FORK CONNECTION WAS LOOSE DUE TO LOOSE SCREWS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THIS LOOSE CONNECTION COULD LEAD TO FALL OFF THE HEADLIGHT, AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE REPAIR WAS CARRIED OUT AND THE JOINT WAS CLEANED AND FRESHLY GREASED. THE CONNECTION WAS DISMANTLED, SCREWS WERE RETIGHTENED WITH USE OF A SCREW LOCK. FUNCTION TEST AND TEST RUN WERE PERFORMED WITH POSITIVE RESULTS. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO LOOSENED CONNECTION BETWEEN HEADLIGHT AND FORK, WHICH CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF THE DEVICE WAS OR WAS NOT BEING USED FOR A PATIENT¿S TREATMENT UPON THE EVENT OCCURRENCE. THE REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE INVESTIGATED ISSUE IS VERY LOW. 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 BRACKET FIXING SCREWS OVER A LONG PERIOD OF TIME. SINCE (B)(6) 2017, THE ASSEMBLY PROCEDURE ¿GOM 5463 IND.O AND GOM5462 IND.M¿ INDICATES THAT THE ORIGINAL SCREWS HAVE BEEN REPLACED BY PRE-GLUED SCREWS.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 (USER MANUAL NU_VOLISTA_01781 EN 18, PAGES 37-38, 94). GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE CORRECTION OF D4 CATALOG # AND D4 VERSION OR MODEL # FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 VERSION OR MODEL # ARD568812960. CORRECTED D4 VERSION OR MODEL # ARD568812960/ARD568811960. PREVIOUS D4 CATALOG # ARD568812960. CORRECTED D4 CATALOG # ARD568812960/ARD568811960.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - THE CONFIGURATION OF TWO HEADLIGHTS VOLISTA STANDOP 400 AND 600. IT WAS STATED THE HEADLIGHT TO FORK CONNECTION WAS LOOSE DUE TO LOOSE SCREWS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THIS LOOSE CONNECTION COULD LEAD TO FALL OF THE HEADLIGHT AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968816 VOLISTA STANDOP 400 / 600 LAMP, SURGICAL FTD MAQUET SAS ARD568812960/ARD568811960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown