BEUDAMED
    FDA Adverse Event Summary report: N

    VALTCHEV

    MDR report key: 8239519 · Received January 10, 2019

    Report

    Report Number
    MW5083057
    Date Received
    January 10, 2019
    Date of Event
    December 10, 2018
    Manufacturer
    CONKIN SURGICAL INSTRUMENTS LTD.
    Product Code
    KNA
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A LAPAROSCOPIC BILATERAL SALPINGECTOMY. THE TIP OF THE UTERINE MANIPULATOR (AN INSTRUMENT) BROKE OFF INSIDE THE PT DURING USE. DR WAS ABLE TO RETRIEVE THE BROKEN TIP. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31429 VALTCHEV INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGY KNA CONKIN SURGICAL INSTRUMENTS LTD. VM 4

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR