BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERAMIC INSULATION INTERLUBE RESECTOSCOPE

    MDR report key: 219630 · Received April 16, 1999

    Report

    Report Number
    219630
    Event Type
    Death
    Date Received
    April 16, 1999
    Date of Event
    April 6, 1999
    Report Date
    April 15, 1999
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICAN
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTACT RESECTOSCOPE SHEATH AND OBTURATOR WERE PREASSEMBLED AND FUNCTIONAL AT THE START OF SURGERY. LATER DURING THE PROSTATE RESECTION, A WHITE OBJECT WAS NOTED ON THE TV MONITOR. DR MADE ATTEMPTS TO IRRIGATE THE OBJECT FROM THE BLADDER, THE PROSTATE RESECTION WAS CONTINUED. THE PT BECAME BRADYCARDIC, TREATMENTS WERE STARTED BY ANESTHESIA AND STAFF. DR NOTED ABDOMINAL DISTENSION, THE RESECTOSCOPE WAS REMOVED BY DR AND A DEFECTIVE END WAS NOTED BY THE SURGEON. AN INVENTORY OF ALL RESECTOSCOPE SHEATHS SHOWED ONE OTHER RESECTOSCOPE SHEATH 27040 XB/XD/26040 XB WHICH HAD A HAIRLINE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMIC INSULATION INTERLUBE RESECTOSCOPE RESECTOSCOPE SHEATH FED KARL STORZ ENDOSCOPY-AMERICAN 27040 XB/XD KN01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death