BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 2656004 · Received July 11, 2012

    Report

    Report Number
    MW5026151
    Event Type
    Injury
    Date Received
    July 11, 2012
    Date of Event
    June 25, 2012
    Report Date
    July 3, 2012
    Manufacturer
    MICROTEK MEDICAL INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT TAKEN TO OPERATING ROOM FOR LAPAROSCOPIC CHOLECYSTECTOMY BY DR. (B)(6). DURING USE OF ELECTROCAUTERY PROBE, THE TIP OF ELECTROCAUTERY PROBE TWISTED OFF FELL OFF OF THE CAUTERY INSTRUMENT AND WAS NOT EASILY IDENTIFIABLE BUT IT WAS THEN IN PT'S ABDOMEN. FLUOROSCOPY WAS BROUGHT IN AND THE TIP OF THE PROBE WAS IDENTIFIED BEHIND THE LIVER. EXTENSIVE EXPLORATION WAS NECESSARY AND AFTER 2.5 HRS THE PROBE WAS FINALLY IDENTIFIED AND IT WAS REMOVED THROUGH THE UMBILICAL PORT ALONG WITH THE GALLBLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI CAUTERY HOOK, A-SURE 5MM 10 PACK NAY MICROTEK MEDICAL INC 400156-04 C11283

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention