BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSENTERIX

    MDR report key: 2100936 · Received May 18, 2011

    Report

    Report Number
    MW5020676
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    December 9, 2010
    Report Date
    May 18, 2011
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(6), 2010, (B)(6) WAS ADMITTED TO (B)(6) FOR LAP BAND SURGERY. IT WAS PERFORMED BY DR. (B)(6) WHO USED THE TRANSENTERIX SPIDER EQUIPMENT FOR THIS SURGERY. (B)(6) IMMEDIATELY REPORTED EXTREME PAIN. THE LAP BAND WAS REMOVED ON (B)(6) 2010 BY DR (B)(6) AT LARGO MEDICAL CENTER AT (B)(6). SHE WAS THEN PLACED INTO ICU FOR 30 DAYS AND THEN AN ADDITIONAL 9 DAYS IN THE REGULAR HOSPITAL. ON (B)(6) 2010 DR (B)(6) GAVE ME THE OPERATIVE PHOTOS SHOWING ABNORMAL BURN OR ULCERATION ANYPLACE THE LAP BAND WAS. THIS WAS NOT AN ALLERGIC REACTION NOR A REJECTION. DR. (B)(6) CLAIMS IGNORANCE AS TO THE CAUSE OF THE PROBLEM. BEFORE (B)(6) LEFT THE HOSPITAL SHE HAD 4 JP DRAINS TO DRAIN FISTULAE AND THE FLUID WAS IN THE WOUND ALSO. (B)(6) LEFT THE HOSPITAL WITH A WOUND VAC FOR A VERY LARGE AND VERY DEEP WOUND. SHE NEEDED RETURN VISITS FOR THE WOUND VAC CHANGES. (B)(6) HAD NO ISSUES PRIOR TO THE SURGERY AND IF THIS WAS NOT SURGEON ERROR IT WAS DEFINITELY PRODUCT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSENTERIX SPIDER LAP BAND LTI TRANSENTERIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| L| O