BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUNO 2 EU WITH AUTODRIVE

    MDR report key: 10091555 · Received May 27, 2020

    Report

    Report Number
    3013876692-2020-00025
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 22, 2020
    Report Date
    November 17, 2020
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE POTENTIALLY AFFECTED PRODUCTS (100740A0 - TRACTION BAR WITH BALL JOINT) WERE INVESTIGATED BY A GETINGE-MAQUET SERVICE ENGINEER. THERE ARE TWO PRODUCTS 100740A0 IN THE CLINIC. THEIR SERIAL NUMBERS ARE (B)(6). THE USER COULD NOT TELL, WHICH OF THESE WAS INVOLVED IN THE INCIDENT. THE TRACTION DEVICE WITH SERIAL NUMBER 130 WAS NOT FULLY RELEASING. THIS MAKES IT MORE DIFFICULT TO ATTACHE THE DEVICE TO THE TALBLE. THE TRACTION DEVICE WITH SERIAL NUMBER 46 COULD BE ATTACHED AND DETACHTED FROM/TO THE TABLE EASILY. IN THE INSTRUCTIONS FOR USE (IFU) THE USER IS WARNED AS FOLLOWS CONCERNING THE USE OF DEFECTIVE DEVICES: "WARNING! RISK OF INJURY! FAULTY OR DEFECTIVE PRODUCTS MAY RESULT IN INJURIES. BEFORE USE, CHECK THE PROPER WORKING ORDER AND FULLY FUNCTIONAL STATE OF THE PRODUCT. STOP USING FAULTY OR DEFECTIVE PRODUCTS AND INFORM THE GETINGE REPRESENTATIVE." THE INJURED USER COULD NOT REMEMBER WHERE HIS HAND WAS, WHEN THE INCIDENT OCCURRED. THE RISK OF CRASHING AND SHEARING HAZARDS IS INHERENT DUE TO THE SIZE AND WEIGHT OF THE PRODUCT. IN THE IFU FOR 100740A0 THE USER IS WARNED CONCERNING THESE RISK AS FOLLOWS: "WARNING! RISK OF INJURY! WHENEVER THE PRODUCT IS MOUNTED AND ADJUSTED, THERE IS A DANGER OF PINCHING AND SHEARING TO THE STAFF, PATIENT AND ACCESSORIES. ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS." THE COMPLAINTS DATABASE WAS REVIEWED CONCERNING SIMILAR ISSUES WITH 100740A0 OR THE YUNO II TABLES (143302XX). NO SIMILAR ISSUES WERE REPORTED TO US. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE # 321645.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS MANUFACTURED BY MAQUET GMBH. MAQUET MEDICAL SYSTEMS IS THE IMPORTER OF THIS DEVICE. A FOLLOW-UP IMPORTER MEDICAL DEVICE REPORT WILL BE SUBMITTED ONCE THE RESULTS FROM THE MANUFACTURER ARE AVAILABLE.

    Description of Event or Problem · 1

    AN ACCESSORY CALLED "TRACTION BAR WITH BALL JOINT" (1007.40A0) CAN BE MOUNTED AND DETACHED FROM THE OPERATING TABLE. WHILE MOUNTING THIS ACCESSORY A STAFF MEMBER INJURED THE TIP OF A FINGER. A SURGERY WAS REQUIRED TO REPAIR THE TIP OF THE FINGER. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554606 YUNO 2 EU WITH AUTODRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 143302B0 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 100740A0 TRACTION BAR WITH BALL JOINT| 100740A0 TRACTION BAR WITH BALL JOINT