BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V CARE STANDARD VAGINAL MANIPULATOR

    MDR report key: 2475322 · Received February 27, 2012

    Report

    Report Number
    MW5024461
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 27, 2012
    Manufacturer
    CONMED CORP
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD LAPAROSCOPIC HYSTERECTOMY USING DAVINCI ROBOT. UPON ATTEMPTED REMOVAL OF VAGINAL MANIPULATOR, MANIPULATOR FELL APART. THE TWO CUPS CAME OFF THE SHAFT AND THE BALLOON TORE OFF. THE SURGICAL SERVICES STAFF AND THE PHYSICIAN WERE ABLE TO ACCOUNT FOR ALL PIECES PRIOR TO THE PT LEAVING THE OPERATING ROOM. THIS OCCURRENCE WAS REPEATED THE NEXT DAY; SEE REPORT FOR EVENT ON (B)(6) 2012. DATES OF USE: (B)(6) 2012. REASON FOR USE: MENORRHAGIA/ANEMIA; UTERINE FIBROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V CARE STANDARD VAGINAL MANIPULATOR VAGINAL MANIPULATOR LKF CONMED CORP P/N 17417 1109261

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other