BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ MORCELLATOR

    MDR report key: 315506 · Received February 9, 2001

    Report

    Report Number
    2020550-2001-00006
    Event Type
    Injury
    Date Received
    February 9, 2001
    Date of Event
    October 1, 2000
    Report Date
    February 6, 2001
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DATA AND INFO CONTAINED HEREIN IS BEING SUBMITTED TO THE FDA TO COMPLY WITH THE REGULATIONS (21 CFR PART 803) PERTAINING TO MEDICAL DEVICE REPORTING. THIS MDR IS BASED ON PRELIMINARY INFO RECEIVED BY KARL STORZ, WHO HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE ADVERSE EVENT. THIS MDR IS, THEREFORE, NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION THAT A REPORTABLE EVENT OCCURRED OR THAT ANY KARL STORZ PRODUCT(S) WERE CAUSALLY RELATED TO THE INCIDENT. ALTHOUGH CO IS NOT CERTAIN WHETHER A KARL STORZ MORCELLATOR WAS USED IN THIS CASE, CO IS FILING THIS INCIDENT AS AN MDR. SALES REP WAS TOLD BY A NURSE AT HEALTH CENTER THAT AN ARTICLE IN THE NEWSPAPER A WEEK BEFORE REGARDING AN INJURY TO A PT WAS FROM A KARL STORZ MORCELLATOR LOANED FROM HEALTH CENTER. CO LOCATED A COPY OF NEWSPAPER, THE CHRONICLE-HERALD, DATED 1/11/2001. IT DESCRIBED HOW A DR USED A NEW INSTRUMENT FOR WHICH SHE WAS NOT TRAINED TO REMOVE A PT'S SPLEEN. THE SURGEON LOST CONTROL OF THE INSTRUMENT AND CUT INTO THE GIRL'S KIDNEY, RENAL ARTERY AND SYMPATHETIC NERVES. SINCE A LAWSUIT IS BEING FILED BY THE PT'S PARENTS, NO ADDITIONAL INFO CAN BE OBTAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4931 KARL STORZ MORCELLATOR MORCELLATOR HET KARL STORZ GMBH & CO. KG 26712013 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention