BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3667646 · Received March 7, 2014

    Report

    Report Number
    2955842-2014-01384
    Event Type
    Injury
    Date Received
    March 7, 2014
    Date of Event
    October 17, 2007
    Report Date
    January 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    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. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING 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 THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2007 WHO ALLEGEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS, INCLUDING BOWEL OBSTRUCTION ON POST OPERATIVE DAY 3 AND HAD BLADDER LEAKAGE FROM HIS PROSTATECTOMY, WHICH WAS TREATED WITH A BLADDER SLING. THE PATIENT HAD MULTIPLE HOSPITAL VISITS TO TREAT HIS BOWEL OBSTRUCTION AND ULTIMATELY UNDERWENT 2 ADDITIONAL SURGERIES ON (B)(6) 2011 AND (B)(6) 2011. IT WAS ALSO ALLEGED THAT THE ROBOT MALFUNCTIONED WHICH RESULTED IN INTERNAL BURNS AND NERVE DAMAGE. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE (OP) REPORTS FOR THE DA VINCI SURGERY AS WELL AS ADDITIONAL MEDICAL RECORDS; HOWEVER, THE OPERATIVE REPORTS FOR THE 2 SUBSEQUENT SURGERIES WERE NOT PROVIDED. ACCORDING TO AN OPERATIVE REPORT DATED (B)(4) 2007, THE PATIENT UNDERWENT A DA VINCI ROBOTIC-ASSISTED RADICAL PROSTATECTOMY AND RIGHT PELVIC LYMPHADENECTOMY FOR PROSTATE CANCER. PATIENT WAS DIAGNOSED WITH ADENOCARCINOMA OF THE PROSTATE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION AND NO INDICATIONS OF INTERNAL BURNS OR NERVE DAMAGE. ESTIMATED BLOOD LOSS WAS 100 ML. THE PATIENT'S HOSPITAL COURSE INDICATED THAT THERE WERE NO COMPLICATIONS AND NO POSTOPERATIVE ADVERSE EVENT. THE PATIENT WAS DISCHARGED HOME ON POST OPERATIVE DAY 1 ((B)(6) 2007). NO ADDITIONAL OTHER MEDICAL RECORDS DATED BETWEEN (B)(6) 2007 - (B)(6) 2011 WERE PROVIDED. ADDITIONAL MEDICAL RECORDS INDICATED THAT THE PATIENT RECEIVED MEDICAL ATTENTION FOR SMALL BOWEL OBSTRUCTION IN (B)(6) 2011 THROUGH (B)(6) 2011. AN OPERATIVE REPORT DATED (B)(4) 2011 INDICATED THAT THE PATIENT UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS WITH REPAIR OF VENTRAL HERNIA. ACCORDING TO AN OPERATIVE REPORT DATED (B)(4) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESIONS DUE TO POSSIBLE ADHESIONS WITHIN THE BASE OF THE MESENTERY, LEADING TO POSSIBLE RECURRENT INTERNAL HERNIA. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. NO OTHER MEDICAL RECORDS PAST (B)(6) 2011 WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139287 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R