BEUDAMED
    FDA Adverse Event Death Summary report: N

    DE VINCI SI SURGICAL SYSTEM

    MDR report key: 2192397 · Received July 25, 2011

    Report

    Report Number
    2955842-2011-00245
    Event Type
    Death
    Date Received
    July 25, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 25, 2011
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VIDEO OF THE DA VINCI SI PROCEDURE WAS REVIEWED BY A HOSPITAL PHYSICIAN. IT WAS NOTED THAT THE SURGEON DID NOT CLOSE THE PT'S PERITONEUM. THE PHYSICIAN INFORMED INTUITIVE SURGICAL THAT NO ISSUES WERE OBSERVED DURING THE CASE. THE PHYSICIAN ALSO INDICATED THAT THERE WERE NO SYSTEM, INSTRUMENT OR ACCESSORY ISSUES EXPERIENCED BY THE SURGICAL STAFF DURING THE PROCEDURE. TO THE BEST OF THE PHYSICIAN'S KNOWLEDGE, THERE WERE NO PT COMPLICATIONS DURING THE SURGICAL PROCEDURE. THE HOSPITAL IS CURRENTLY PERFORMING AN INVESTIGATION OF THE EVENT. TO DATE, IT IS UNK HOW THE DAMAGE TO THE PT'S BOWEL WAS INTRODUCED AND THE EXACT CAUSE OF DEATH IS ALSO UNK. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE WAS COMPLETED ON (B)(6) 2011, THE SURGEON RETURNED TO THE HOSPITAL LATER ON THE SAME DAY TO REMOVE THE PT'S Y-MESH USING OPEN SURGICAL TECHNIQUES. THE REASON FOR REMOVING THE Y-MESH IS UNK. ON (B)(6) 2011, THE PT EXPERIENCED SEVERE PAIN AND IT WAS DETERMINED BY THE MEDICAL STAFF THAT THE PT HAD DEVELOPED SEPSIS DUE TO A PERFORATED BOWEL. SUBSEQUENTLY, THE PT EXPIRED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DE VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, NAY NAY INTUITIVE SURGICAL, INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death ACCS.| ESU| DA VINCI SI SURGICAL SYSTEM INSTS.