BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3679062 · Received March 14, 2014

    Report

    Report Number
    2955842-2014-01519
    Event Type
    Injury
    Date Received
    March 14, 2014
    Report Date
    February 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PLEURAL INJURY DURING THE DA VINCI PROCEDURE. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED IN THE REPORTED PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATED THAT A PATIENT SUFFERED A PLEURAL INJURY DURING THE DA VINCI PROCEDURE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) REVIEWED A JOURNAL ARTICLE BY RUPA SEETHARAMAIAH ET AL. TITLED ROBOTIC REPAIR OF GIANT PARAESOPHAGEL HERNIAS. ACCORDING TO THE REPORTED ARTICLE, A (B)(6) HEALTHY WOMAN CAME TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. PEH WAS DIAGNOSED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. DURING THE PROCEDURE, A GPEH WAS FOUND AND THE STOMACH WAS STRONGLY ADHERED TO BOTH THE RIGHT AND LEFT CRUS. DURING THE DISSECTION, A PLEURAL INJURY WAS NOTICED. REDUCTION WAS COMPLETED, THE PLEURAL INJURY WAS REPAIRED WITH NO. 3-0 VICRYL (ETHICON), AND THE HERNIA WAS CLOSED WITH NONABSORBABLE SUTURE. NO PLEURAL TUBE WAS USED. A BIOLOGICAL MESH WAS PLACED AND A NISSEN FUNDOPLICATION PERFORMED. THE TOTAL PROCEDURE WAS COMPLETED IN 258 MINUTES, AND THE PATIENT WAS DISCHARGED 3 DAYS LATER. THE HOSPITAL NAME AND THE DA VINCI SERIAL NUMBER INVOLVED WITH THIS PATIENT WAS NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153995 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention