BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCH KOH EFFICIENT 4.0 CM

    MDR report key: 5127406 · Received September 29, 2015

    Report

    Report Number
    MW5056807
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    May 7, 2015
    Report Date
    September 29, 2015
    Manufacturer
    COOPER SURGICAL
    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

    SURGEON USED THE ARCH KOB-EFFICIENT 4.0 CM (UTERINE MANIPULATOR) COOPER SURGICAL. THIS IS A DISPOSABLE MEDICAL DEVICE USED DURING A LAP SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGECTOMY. THE BLUE COP BROKE OFF FROM MEDICAL DEVICE WITHOUT THE SURGEON OR HOSPITAL STAFF AWARENESS. THE BLUE CUP WAS FOUND 5 MONTHS LATER; RETAINED IN PT. THE BLUE CUP SHOULD HAVE NOT BROKEN OFF. TWO SUPRAPUBIC 5-MM PORTS AND AN INCISION IN THE UMBILICUS THROUGH THE PERITONEUM. THROUGH THIS INCISION A GELPOINT RETRACTOR WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642370 ARCH KOH EFFICIENT 4.0 CM UTERINE MANIPULATOR LKF COOPER SURGICAL KC-ARCH-40 154764

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R