BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3034918 · Received March 15, 2013

    Report

    Report Number
    9610617-2013-00010
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 14, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FCL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT RETURNED; HOSPITAL STATED, THE INSULATION WAS BREACHED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A LAP FUNDOPLICATION WHEN THE INSTRUMENT ARCED RESULTING IN A MINOR BURN TO THE INTESTINES. NO MEDICAL ATTENTION WAS NEEDED FOR THE BURN; PROCEDURE WAS COMPLETED. PT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110404 KARL STORZ DISSECTING ELECTRODE FCL KARL STORZ GMBH & CO. KG 26870UFS EB

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other