BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET EXTENSION DEVICE TO YUNO OR TABLE

    MDR report key: 2862302 · Received November 28, 2012

    Report

    Report Number
    8010652-2012-00014
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MAQUET GMBH
    Product Code
    FWZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET HAS TRACED THE SOURCE OF THE INJURY TO A MISSING GUARD ON THE EXTENSION DEVICE. THIS GUARD IS MOUNTED TO THE EXTENSION DURING THE ASSEMBLY PROCESS AND IS NOT A REMOVABLE PART. MAQUET HAS INITIATED AN INVESTIGATION OF THIS EVENT. ADD'L INFO WILL BE PROVIDED IN A F/U REPORT. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    DURING A DIRECT ANTERIOR APPROACH TO TOTAL HIP ARTHROPLASTY, A MALE NURSE OPERATING THE YUNO EXTENSION DEVICE, PINCHED HIS HAND ON THE TABLE BETWEEN HIS THUMB AND INDEX FINGER, RECEIVING A MINOR CUT. GAUZE AND TAPE WERE USED TO STOP THE BLEEDING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET EXTENSION DEVICE TO YUNO OR TABLE ACCESSORIES, OPERATING-ROOM, TABLE, FWZ FWZ MAQUET GMBH 1433.62A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI