BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOMAT LC PUMP FOR SUCTION ONLY

    MDR report key: 6942963 · Received October 11, 2017

    Report

    Report Number
    9610617-2017-00086
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 13, 2017
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    OCX
    UDI-DI
    04048551066423
    PMA / PMN Number
    K031457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE HOSPITAL, THEY WIL NOT RETURN THE UNIT SINCE IT WAS USER ERROR.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A TURP PROCEDURE, THE ENDOMAT PUMP TUBING WAS MISTAKENLY HOOKED UP BACKWARDS. THE DOCTOR NOTICED THE FLUID WAS COMING INFLOW INSTEAD OF OUTFLOW. THE HOSPITAL DID NOT BELIEVE THE WASTE FLUID REACHED THE PATIENT'S BLADDER BUT, AS A PRECAUTION, IV ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. HOSPITAL REPORTED THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A TURP PROCEDURE, THE ENDOMAT PUMP TUBING WAS MISTAKENLY HOOKED UP BACKWARDS. THE HOSPITAL DID NOT BELIEVE THE WASTE FLUID REACHED THE PATIENT'S BLADDER BUT, AS A PRECAUTION, IV ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. HOSPITAL REPORTED THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719589 ENDOMAT LC PUMP FOR SUCTION ONLY SUCTION PUMP OCX KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 20330320-1 04048551066423

    Patients

    Seq Age Sex Outcome Treatment
    1