BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 508913 · Received January 21, 2004

    Report

    Report Number
    MW1030918
    Event Type
    Injury
    Date Received
    January 21, 2004
    Date of Event
    January 12, 2004
    Report Date
    January 21, 2004
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    KQT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE THE UROLOGY CONTINUOUS FLOW PUMP WAS CONNECTED INCORRECTLY RESULTING IN AIR BEING PUMPED INTO BLADDER RATHER THAN FLUID EVACUATED. THIS RESULTED IN BLADDER PERFORATION, PNEUMOPERITONEUM AND PNEUMOTHORAX, AND HEMODYNAMIC CHANGES LEADING TO CARDIAC ARREST WITH SUCCESSFUL RESUSCITATIVE EFFORTS. OPEN LAPAROTOMY WAS PERFORMED TO REPAIR THE BLADDER AND PT WAS TRANSFERRED TO INTENSIVE CARE FOR POST-OP MANAGEMENT. STAFF RE-EDUCATED REGARDING USE OF EQUIPMENT HOWEVER A CONCERN HAS BEEN IDENTIFIED WITH THE EQUIPMENT THAT ALLOWS INCORRECT CONNECTIONS AND REPORTER IS CONCERNED THAT THIS MAY BE AN EQUIPMENT DESIGN FLAW.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/19/2004: AS STATED IN THE REPORT, THE HOSPITAL'S BIO-MED HAS EVALUATED THE UNIT AND CONFIRMED IT WAS IN OPERATIONAL CONDITION AND THAT THEY DO NOT CONSIDER THERE WAS A NEED TO RETURN THE UNIT FOR EVALUATION. THIS HOSPITAL HAS HAD THE PUMP FOR OVER 12 YEARS, IT HAS NEVER BEEN RETURNED FOR REPAIR OR MAINTENANCE. WHEN THIS PRODUCT WAS FIRST INTRODUCED TO THE MARKET IN 1983 (K832009), IT HAD CLEAR DIRECTIONS OF "TO WASTE" AND "FROM INSTRUMENT" ON THE FACEPLATE. MFR THEN ADDED A PLASTIC PLATE OVER THE PUMP HEAD (DECEMBER 1991) WITH BRIGHT YELLOW CAUTION STATEMENT AND BIG ARROWS SHOWING THE DIRECTION OF THE FLOW. IN 2002, MFR ADDED ANOTHER SET OF BRIGHT YELLOW STICKERS TO THE FACEPLATE DUPLICATING THE DIRECTION OF THE FLOW, JUST IN CASE CUSTOMER DID NOT HAVE THE YELLOW PLATE ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ UROLOGY CONTINUOUS FLOW PUMP KQT KARL STORZ ENDOSCOPY 27224P *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R