BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD SURGICAL TABLE

    MDR report key: 2956780 · Received February 5, 2013

    Report

    Report Number
    MW5028920
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THIS PT WAS UNDERGOING A LAPAROSCOPIC NEPHROURETERECTOMY. DURING THE SURGICAL PROCEDURE, THE BERCHTOLD TABLE UNCONTROLLABLY ROSE WHILE THE DAVINCI WAS DOCKED. THE TABLE RAISED INTO THE BODY CAMERA, CAUSING BLUNT TRAUMA TO THE BOWEL. THE BED WAS MANUALLY LOWERED AND UNPLUGGED FROM ANY ELECTRICITY FOR COMPLETION OF THE SURGICAL CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47998 BERCHTOLD SURGICAL TABLE BERCHTOLD SURGICAL TABLE FQO BERCHTOLD CORP BERCHTOLD SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other