BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOH CUP

    MDR report key: 1190303 · Received October 6, 2008

    Report

    Report Number
    1216677-2008-00033
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    July 29, 2008
    Report Date
    October 6, 2008
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN KEEPING WITH GOOD MEDICAL PRACTICE, THE PHYSICIAN HAS THE RESPONSIBILITY TO ENSURE ALL NON-IMPLANTABLE DEVICES ARE REMOVED FROM THE PT. ALTHOUGH THIS PRACTICE SHOULD BE KNOWN BY THE PHYSICIAN, THE INSTRUCTIONS FOR USE ARE IN THE PROCESS OF BEING REVISED TO ADDING A STATEMENT TO CHECK THE SYSTEM UPON REMOVAL, TO ENSURE IT IS INTACT.

    Description of Event or Problem · 1

    DURING A TLH, A KOH CUP WAS LEFT BEHIND IN THE PT. PT PRESENTED TO THE ER 2X IN THE MONTH POST SURGERY, COMPLAINING FEELING LIKE SITTING ON AN EGG AND SOME ABDOMINAL PAIN. CT SCAN WAS PERFORMED, BUT THE KOH CUP WAS NOT DETECTED. LATE AUGUST, DOCTOR PERFORMED AN EXAM FINDING THE KOH CUP RETAINED IN THE PATIENT'S VAGINA. PT WAS TAKEN TO THE OR, A SPINAL WAS DONE AND THE KOH CUP WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOH CUP COLPOTOMIZER SYSTEM HEW COOPERSURGICAL, INC. KCP-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention