BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERATING TABLE TRUSYSTEM 7000 U (DV)

    MDR report key: 13826091 · Received March 19, 2022

    Report

    Report Number
    3007143268-2022-00004
    Event Type
    Injury
    Date Received
    March 19, 2022
    Report Date
    March 17, 2022
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO MALFUNCTION OF THE MEDICAL DEVICE WAS ALLEGED OR IDENTIFIED. WITHIN THE IFU IT IS REQUIRED TO ENSURE THAT NO CABLES OR OTHER PARTS ARE IN THE AREA OF THE FLOOR LOCKS. FURTHER, WARNINGS ARE INCLUDED FOR MOVING PARTS AND THE POTENTIAL OF CRUSHING IN THE AREA OF THE FLOOR LOCKS. THE ROOT CAUSE OF THE EVENT WAS DETERMINED AS AN USER ERROR. THE NURSE PUT HER HAND IN PLACE WHERE FLOOR LOCKS WERE COMING OUT. SEVERAL ATTEMPTS WERE MADE TO THE CUSTOMER TO DETERMINE THE SEVERITY OF HARM AND PROVIDE CORRECT DEVICE INFORMATION (E.G. SERIAL NUMBER). HOWEVER, ONLY A "BROKEN FINGER" WAS REPORTED. TRUMPF MEDICAL IS REPORTING THIS EVENT BASED ON THE POSSIBILITY ON A SERIOUS INJURY CAUSED BY THIS USER ERROR. WE ARE NOT AWARE OF ANY SIMILAR EVENT. BASED ON THE RESULTS NO ACTIONS ARE NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE END OF A SURGICAL PROCEDURE THE OPERATING TABLE TRUSYSTEM 7000 WAS REPOSITIONED AND SHOULD BE LOCKED. A NURSE NOTICED SOME CABLES AT THE AREA WHERE THE FLOOR LOCKS WERE COMING OUT. SHE WENT TO MOVE THE CABLES USING HER HAND AND FINGER, THEN SHE WAS CAUGHT UNDERNEATH THE LOCKS; THUS RESULTING IN A BROKEN FINGER. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605 OPERATING TABLE TRUSYSTEM 7000 U (DV) SURGICAL TABLE GDC TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1723633

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown