BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4237984 · Received November 7, 2014

    Report

    Report Number
    2955842-2014-05627
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION. ISI HAS ATTEMPTED TO CONTACT THE SURGEON AND SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF 09/26/2014 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE SUSTAINED A BILE LEAK. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2014, THE PATIENT WAS READMITTED DUE TO EXPERIENCING A BILE LEAK. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SURGEON REPORTEDLY INFORMED THE INITIAL REPORTER THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. APPROXIMATELY TWO DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL WITH UPPER QUADRANT PAIN. THE PATIENT WAS FOUND TO HAVE A BILE LEAK. THE SURGEON INDICATED THAT SHE DID NOT EXPERIENCE ANY ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT USED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720531 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention