BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3205845 · Received July 3, 2013

    Report

    Report Number
    2955842-2013-02424
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE ATTORNEY REPRESENTING THE SURGEON RESPONDED INDICATING THAT AT THIS TIME THE SURGEON IS UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT DUE TO LEGAL CONSTRAINTS. A REVIEW OF THE SITE'S SYSTEM LOG FOR THE REPORTED PROCEDURE DATE FOUND NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURIES SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGATION THAT A PATIENT SUSTAINED INJURIES DURING DA VINCI SURGICAL PROCEDURE. DUE TO THE LIMITED INFORMATION PROVIDED, AT THIS TIME, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURIES SUSTAINED BY THE PATIENT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 2, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT'S OPERATIVE (OP) REPORT FOR THE PRIMARY SURGICAL PROCEDURE AND HOSPITAL, OFFICE AND RADIOLOGY REPORTS. ACCORDING TO THE PATIENT'S OP REPORT, ON (B)(6) 2011 THE PATIENT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATIC ADENOCARCINOMA. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL, OFFICE, AND RADIOLOGY REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SI SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION, HOWEVER A HEMO-LOCK CLIP LATER MIGRATED FROM A SITE OF PLACEMENT THROUGH TO ALTERNATE SITE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH SYMPTOMS OF SMALL BOWEL OBSTRUCTION AND POSSIBLE LEAKING ANASTOMOSIS. AN EMERGENCY LAPAROTOMY FAILED TO SHOW COLORECTAL FISTULA. ADHESIONS AND SMALL URINOMA. ON (B)(6) 2011, CYSTOSCOPY WITH EXTRACTION OF HEMOLOCK CLIP FROM BLADDER NECK AND ON (B)(6) 2012 THE COLOSTOMY WAS REVERSED. PATIENT HAD MULTIPLE COMPLAINTS OF RECTAL ITCHING.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE SUSTAINED BLADDER AND PELVIC WALL INJURIES. REPORTEDLY THE INJURIES SUSTAINED BY THE PATIENT CAUSED A SMALL BOWEL OBSTRUCTION WITH FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304894 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R DA VINCI SI SURG SYS, INSTRUMENTS, ACCESS & ESU