BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWIVEL ARM FOR 25 KGS. VAE/VAG

    MDR report key: 5524341 · Received March 24, 2016

    Report

    Report Number
    0008010153-2016-00026
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 25, 2016
    Report Date
    February 26, 2016
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CENTRAL BEARING SHAFT FOR THE HORIZONTAL ARM IS ALLEGEDLY BROKEN. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WENT ONSITE AND PERFORMED A VISUAL INSPECTION. THE HORIZONTAL ARM HAS BEEN REMOVED FROM THE DROP TUBE, SO THERE IS NO RISK OF FALLING PARTS. THE PARTS HAVE BEEN SHIPPED TO THE MANUFACTURER FOR EVALUATION. A SUPPLEMENTAL WILL BE FILED UP THE CLOSE OF THE INVESTIGATION. THERE WERE NOT REPORTED INJURIES OR ADVERSE CONSEQUENCES WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    ON 8 APRIL 2016, THE PRODUCT INVESTIGATION WAS COMPLETED BY STRYKER TUTTLINGEN (B)(4) . THE SYSTEM WAS REVIEWED AND THE FAILURE POINT WAS CONFIRMED. IT WAS NOTED THAT THE LIGHT ARM RECEIVED A LARGE UPWARD FORCE, POSSIBLY FROM OTHER EQUIPMENT IN THE ROOM. THIS ARM IS NOT INTENDED TO MOVE UPWARD; THEREFORE, THIS MOVEMENT CAUSED THE SEPARATION. THE SYSTEM HAD A SAFETY MEASURE STILL INTACT THAT WOULD PREVENT THE CARDANIC FROM DETACHING FROM THE REST OF THE LIGHT SYSTEM. USE ERROR WAS THE ROOT CAUSE FOR THE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL BEARING SHAFT FOR THE HORIZONTAL ARM IS ALLEGEDLY BROKEN. THERE WERE NOT REPORTED INJURIES OR ADVERSE CONSEQUENCES WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL BEARING SHAFT FOR THE HORIZONTAL ARM IS ALLEGEDLY BROKEN. THERE WERE NOT REPORTED INJURIES OR ADVERSE CONSEQUENCES WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179797 SWIVEL ARM FOR 25 KGS. VAE/VAG SURGICAL LIGHT FSY BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1