BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCARE MEDIUM

    MDR report key: 5127394 · Received September 29, 2015

    Report

    Report Number
    MW5056806
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    July 20, 2015
    Report Date
    September 29, 2015
    Manufacturer
    CONMED
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LAP HYSTERECTOMY BILATERAL SALPINGECTOMY WITH CYSTOSCOPY ON (B)(6) 2015. A MEDIUM VCARE UTERINE MANIPULATOR DISPOSABLE DEVICE WAS USED DURING THE SURGERY. THE GREEN CUP CAME OFF DURING THE SURGERY WITHOUT THE SURGEON AWARENESS. THE GREEN CAP WAS REMOVED DURING A POST OP VISIT. THE CAP SHOULD HAVE NOT COME OFF DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642464 VCARE MEDIUM VAGINAL CERVICAL AHLUWALIA'S RET LKF CONMED 60-6085-201 201506011

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R