BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SATELITE

    MDR report key: 11649648 · Received April 12, 2021

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    9710055-2021-00130
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 5, 2021
    Report Date
    July 26, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH SATELITE DEVICE. THE BRAKE SCREW DETACHED. 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. THE REPAIR WAS PERFORMED AND THE DEVICE WAS RETURNED TO USAGE. DURING THE INVESTIGATION, IT WAS CONCLUDED THAT THE DEVICE INVOLVED DID NOT MEET THE MANUFACTURER¿S SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. WE HAVE NOT RECEIVED INFORMATION WHETHER THE DEVICE WAS BEING USED FOR PATIENT TREATMENT AT THE TIME WHEN THE EVENT OCCURRED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE. PER THE INVESTIGATION OF THE SUBJECT MATTER EXPERTS AT THE MANUFACTURING SITE, THE MOST PROBABLE ROOT CAUSE WAS ESTABLISHED AS INSTALLATION ERROR. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO 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

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH SATELITE DEVICE. THE BRAKE SCREW DETACHED. 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
    547496 SATELITE HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD515032140A

    Patients

    Seq Age Sex Outcome Treatment
    1