BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1739015 · Received June 23, 2010

    Report

    Report Number
    1221826-2010-00015
    Event Type
    Other
    Date Received
    June 23, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 23, 2010
    Manufacturer
    KARL STORZ ENDOVISION, INC.
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR HAD LIGHT SOURCE SET AT 100% INTENSITY AND DID NOT PUT IT ON STANDBY BEFORE HE SET INSTRUMENTS DOWN ON PT. THERE WAS NO REPORT OF MALFUNCTION OF LIGHT CABLE OR LIGHT SOURCE; HOSP RELEASED IT BACK INTO CIRCULATION.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A BREAST AUGMENTATION THE DOCTOR LAID A NON-KARL STORZ RETRACTOR ATTACHED TO ACTIVE LIGHT CABLE ON THE PT'S CHEST WHILE HE TURNED AWAY MOMENTARILY; WHEN HE RETRIEVED INSTRUMENT HE DISCOVERED PT HAD REC'D 3 SMALL BURNS IN THE CHEST AREA. THE BURNS OCCURRED WHERE THE COUPLER BETWEEN THE TWO INSTRUMENTS MADE CONTACT WITH THE SKIN. PT WAS TREATED WITH BACITRACIN. PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LIGHT CABLE FFS KARL STORZ ENDOVISION, INC. 495NE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other