BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1724579 · Received June 12, 2010

    Report

    Report Number
    9610617-2010-00014
    Event Type
    Other
    Date Received
    June 12, 2010
    Date of Event
    April 22, 2010
    Report Date
    June 10, 2010
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATING ROOM WAS USING AN ASPEN ESU THAT ALLOW 2 INSTRUMENTS TO BE PLUGGED IN, BUT ONLY ONE INSTRUMENT CAN BE ACTIVATED AT A TIME. DOCTOR MAY HAVE INADVERTENTLY DEPRESSED THE WRONG FOOT SWITCH AND ACTIVATED THE CLICKLINE ASSEMBLY (INSERT, OUTER TUBE AND HANDLE). HOSPITAL HIPOT TESTED AND HANDLE AND IT PASSED; THERE WAS NO CURRENT LEAKAGE. HOSP DECIDED NOT TO RETURN INSTRUMENT DUE TO NO MALFUNCTION, BUT LATER CHANGED THEIR MIND; WE HAVE NOT REC'D IT BACK YET.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING BREAST ARGUMENTATION, DOCTOR LAID AN INACTIVE CLINCKLINE INSTRUMENT SET ON PT; WHEN HE PICKED UP INSTRUMENT, HE DISCOVERED THAT PT HAD REC'D A BURN IN THE SHAPE OF THE THUMB RING ON THE HANDLE. PT WAS TREATED WITH BACTRICIN AND IS HEALING WELL. PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CLICKLINE INSULATED HANDLE HET KARL STORZ GMBH & CO. KG 33125 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR