BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS FLOW PUMP

    MDR report key: 7047457 · Received November 20, 2017

    Report

    Report Number
    1221826-2017-00093
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 20, 2017
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    OCX
    UDI-DI
    04048551366837
    PMA / PMN Number
    K832009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE FLOW PUMP FOR SERVICE ON (B)(6) 2017 AND THERE WAS NO MENTION OF AN MDR ASSOCIATED WITH THIS UNIT. LATER, WE RECEIVED AN MDR FROM THE CUSTOMER ON (B)(6) 2017. OUR SERVICE DEPT. FOUND THAT PLEXIGLASS PLATE IS BROKEN ON THE PUMP HEAD. THE PLEXIGLASS PLATE SHOWS THE DIRECTION OF FLOW. THE FLOW MECHANISM IS RUNNING IN THE PROPER DIRECTION. THE CORD WRAP HAS A BEND. THE PHYSICAL DAMAGE TO THE PUMP DID NOT AND CANNOT AFFECT THE PERFORMANCE OF THE PUMP.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A TURP PROCEDURE, WHILE KARL STORZ CONTINUOUS FLOW PUMP WAS USED, THE USER EXPERIENCED PROBLEMS WITH THE FLOW CONNECTION FOR THE RESECTOSCOPE. THEY CLAIMED THAT "PRESSURE WAS INTRODUCED FROM THE TUBING RATHER THAN WITHDRAWN FROM THE SCOPE. THE BLADDER APPEARED TAUGHT ( TOUGH? ) TO THE SURGEON. THE TUBING WAS TIGHTENED AND FLUID STARTED DRAINING OUT. THE PROBLEM WAS CORRECTED, AND PROCEDURE WAS COMPLETED. THE PATIENT HAD POST OP ABDOMINAL PAIN. CAT SCAN REVEALED A PERFORATED BLADDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826775 CONTINUOUS FLOW PUMP FLOW PUMP OCX KARL STORZ ENDOVISION 27224P 04048551366837

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other