BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 15353 · Received January 24, 1994

    Report

    Report Number
    2429304-1993-00219
    Event Type
    Injury
    Date Received
    January 24, 1994
    Date of Event
    November 9, 1993
    Report Date
    November 11, 1993
    Manufacturer
    NORTECH
    Product Code
    KDH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HEAD NURSE OF ENDOSCOPY HOOKED UP THE ASPIRATION TUBING FOR THE SP-2 (HYDRO PUMP) UPSIDE DOWN CAUSING THE AIR TO BE PUMPED BACK INTO THE BLADDER WHICH CAUSED THE BLADDER TO RUPTURE. THE PT IS A 72 YEAR OLD MALE AND A CATHETER WAS INSERTED INTO THE BLADDER. THE CATHETER WILL REMAIN IN THE BLADDER FOR APPROX. 8-10 DAYS IN WHICH TIME THE BLADDER IS EXPECTED TO HEAL.. THE ORIGINAL MFG. OF THE DEVICE HAS BEEN INFORMED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ASPIRATION TUBING KDH NORTECH ASPIRATION TUBING UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention