BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SATELITE

    MDR report key: 12088432 · Received June 29, 2021

    Report

    Report Number
    9710055-2021-00237
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 27, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH SATELITE CEILING MOUNTED DEVICE HOLDER. THE SPRING ARM'S DUST COVER 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. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT DID NOT MEET ITS SPECIFICATION AS THE COVER WAS MISSING AND IT CONTRIBUTED TO EVENT. THERE IS NO INFORMATION WHETHER THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. THE POSSIBLE 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. WE BELIEVE THAT THIS TYPE OF OUR DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. THE CORRECTION OF D4 SERIAL # FIELD DEEMS REQUIRED. THIS IS BASED ON THE INFORMATION PROVIDED BY SERVICE UNIT. PREVIOUS D4 SERIAL # (B)(6). CORRECTED D4 SERIAL # (B)(6).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH SATELITE CEILING MOUNTED DEVICE HOLDER. THE SPRING ARM'S DUST COVER 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
    983706 SATELITE HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARDEQT239003A

    Patients

    Seq Age Sex Outcome Treatment
    1