BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3444473 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04995
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    June 22, 2011
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY FOR CHRONIC PAIN AND UTERINE LEIOMYOMATA ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. HOWEVER, THERE WAS AN INADVERTENT CYSTOTOMY PERFORMED AT THE APEX OF THE BLADDER DUE TO EXTENSIVE INTRAABDOMINAL ADHESIONS AND A SMALL BOWEL HERNIA INVOLVING SMALL BOWEL, BLADDER AND THE ANTERIOR ABDOMINAL WALL PERITONEUM. THIS CYSTOTOMY WAS CLOSED PRIMARILY WITH A WATERTIGHT TWO-LAYERED CLOSURE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND WAS FELT TO HAVE A DRAINING HEMATOMA. THE SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562172 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R DAV SI SURG SYS INSTRUMENTS, ACCESSORIES & ESU