BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3900640 · Received June 27, 2014

    Report

    Report Number
    2955842-2014-03959
    Event Type
    Other
    Date Received
    June 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS THAT OCCURRED WHEN THE TWO PATIENTS UNDERWENT DA VINCI PROCEDURES. IN THE ARTICLE, NO PROCEDURE DATES, SURGEON NAME(S) OR HOSPITAL NAME(S) WERE PROVIDED. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT AND/OR ACCESSORY OCCURRED DURING THE REPORTED PROCEDURES. IT IS UNCLEAR WHAT TECHNICAL DIFFICULTIES THE SURGICAL STAFF ENCOUNTERED IN ONE OF THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE PRIMARY REPORTER OF THIS ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENTS; 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 ONE PATIENT REQUIRED AN OPEN SURGERY AND ANOTHER PATIENT SUFFERED A SMALL COLONIC INJURY AFTER SURGERY.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE INITIAL REPORTER OF THIS COMPLAINT CONTACTED INTUITIVE SURGICAL, INC. (ISI) AND PROVIDED THE FOLLOWING INFORMATION: IN REGARDS TO THE FOLLOWING ARTICLE STATEMENT, ONE OF THE PATIENT IN GROUP 1 WHICH REQUIRED CONVERSION TO OPEN SURGERY BECAUSE OF TECHNICAL DIFFICULTIES, THE INITIAL REPORTER EXPLAINED THAT THE TECHNICAL DIFFICULTIES WERE RELATED TO DIFFICULTY WITH DISSECTION OF THE RENAL PELVIS DUE TO PREVIOUS INFECTION AND SCAR TISSUE FORMATION. THE TOTAL SURGERY WAS APPROXIMATELY 200 MINUTES. PER THE INITIAL REPORTER, THE DISSECTION OF THE PELVIS, WAS DIFFICULT AND IT WAS SUPPOSED TO BE LIKE THIS WITH OR WITHOUT THE ROBOT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO REPORTED ISSUES. THE DATE OF THIS PARTICULAR SURGERY WAS ON (B)(6) 2002 AND THE PROCEDURE WAS DONE AT (B)(6). THE SYSTEM WAS TESTED PRIOR TO USE AND THERE WAS NO ISSUES NOTED WITH THE DA VINCI SURGICAL SYSTEM. THE PATIENT WAS A (B)(6) MALE WHO UNDERWENT THIS PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. BASED ON THE ABOVE INFORMATION PROVIDED, THIS PARTICULAR EVENT IS DEEMED NON-REPORTABLE AS THE CASE WAS CONVERTED DUE TO THE PATIENT'S ANATOMY. THERE WAS NO EVIDENCE THAT THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT THE DA VINCI SURGICAL SYSTEM MALFUNCTIONED. IN REGARDS TO THE FOLLOWING ARTICLE STATEMENT, ONE PATIENT IN GROUP 2, WITH A HISTORY OF HEMORRHAGIC RECTOCOLITIS, PRESENTED WITH PERITONITIS POSTOPERATIVELY DUE TO A SMALL COLONIC INJURY. A SECONDARY PROCEDURE WAS PERFORMED AFTER THE PATIENT HAD AN UNEVENTFUL RECOVERY, THE INITIAL REPORTER MENTIONED THAT THE DATE OF PROCEDURE WAS ON (B)(6) 2008 AND THE SURGERY TOOK PLACE AT (B)(6). THE DA VINCI SURGICAL SYSTEM WAS INSPECTED PRIOR TO USE WITH NO PROBLEMS NOTED WITH THE SYSTEM. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO SPECIFIC ISSUES IN THE INITIAL POST-OP PERIOD. HOWEVER, THE PATIENT PRESENTED SIGNS OF PERITONITIS ON POST-OPERATIVE DAY 7. THE PATIENT CAME BACK TO THE HOSPITAL FOR THE SECOND PROCEDURE ON (B)(6) 2008. THE PATIENT'S RECOVERY FROM THE SECOND PROCEDURE WAS UNEVENTFUL. AFTER A ONE YEAR FOLLOW-UP, A TOTAL COLECTOMY WAS DEEMED NECESSARY IN ORDER TO CONTROL THIS PATIENT'S EXTENSIVE INFLAMMATORY BOWEL DISEASE. THE PATIENT WAS A (B)(6) MALE WHO UNDERWENT THIS PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER.

    Description of Event or Problem · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) REVIEWED A JOURNAL ARTICLE TITLED, ROBOTIC LAPAROSCOPIC PYELOPLASTY. THIS ARTICLE COMES FROM THE JOURNAL OF SOCIETY OF LAPAROENDOSCOPIC SURGEONS VOLUME 18, ISSUE 1, JANUARY - MARCH 2014. ACCORDING TO THE REPORTED ARTICLE,ONE PATIENT IN GROUP 1 REQUIRED CONVERSION TO OPEN SURGERY BECAUSE OF TECHNICAL DIFFICULTIES. ONE PATIENT IN GROUP 2, WITH A HISTORY OF HEMORRHAGIC RECTOCOLITIS, PRESENTED WITH PERITONITIS POSTOPERATIVELY DUE TO A SMALL COLONIC INJURY. A SECONDARY PROCEDURE WAS PERFORMED AFTER THE PATIENT HAD AN UNEVENTFUL RECOVERY. THE HOSPITAL NAMES AND THE DA VINCI SERIAL NUMBERS INVOLVED WITH THESE PATIENTS WERE NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377985 DA VINCI SURGICAL SYSTEM ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R