BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1923308 · Received December 3, 2010

    Report

    Report Number
    9610617-2010-00040
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVAL. HOSPITAL PUT THE SCOPE BACK INTO CIRCULATION. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING AN APPENDECTOMY PROCEDURE, A 10MM LAPAROSCOPE WAS USED, THE SURGEON FOUND SCOPE TO BE FOGGY AND "WIPED" THE SCOPE ON THE INTESTINE AND NOTICED A BURN ON THE INTESTINE. PROCEDURE WAS COMPLETED. HOSPITAL WILL NOT RELEASE ANY INFO ON POST-OP CONDITION OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ RIGID SCOPE FBP KARL STORZ GMBH & CO. KG 26003BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other