BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3183244 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02270
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 5, 2011
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PATIENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE PATIENT INDICATED THAT SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011, AND THAT FOR APPROXIMATELY 5 TO 8 DAYS POST OP, SHE EXPERIENCED PAIN AND BLEEDING. THE PATIENT INDICATED THAT SINCE THE PROCEDURE, SHE HAS EXPERIENCED A CONTINUITY OF PAIN IN HER RECTUM, VAGINA AND BLADDER AND HAS UNDERGONE MULTIPLE PHYSICAL EXAMINATIONS DUE TO HER PAIN. THE PATIENT HAS BEEN PRESCRIBED APPROXIMATELY 15 DIFFERENT MEDICATIONS TO MANAGE HER PAIN. SHE IS CURRENTLY TAKING MORPHINE. THE PATIENT ALSO INDICATED THAT POST-OPERATIVELY SHE EXPERIENCED VAGINAL CUFF AND RECTUM EVISCERATION; HOWEVER, SHE HAS NOT UNDERGONE ANY ADDITIONAL SURGICAL PROCEDURE TO REPAIR THESE CONDITIONS. THE PATIENT INDICATED AT THAT TIME THAT SHE WOULD MAIL COPIES OF HER MEDICAL RECORDS TO ISI. ON (B)(4) 2013 INTUITIVE SURGICAL CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE FOR ADDITIONAL INFORMATION REGARDING THE PATIENT'S REPORT. ON (B)(4) 2013, A RESPONSE WAS RECEIVED FROM THE HOSPITAL'S RISK MANAGER INDICATING THAT THEY WERE UNABLE TO SHARE ANY PATIENT HISTORY INFORMATION WITHOUT A SIGNED RELEASE AUTHORIZATION FROM THE PATIENT. ON (B)(4) 2013 ISI CONTACTED THE PATIENT REGARDING THE STATUS OF HER MEDICAL RECORDS. THE PATIENT INDICATED THAT SHE HAS MADE THE DECISION NOT TO PROVIDE ISI WITH COPIES OF HER MEDICAL RECORDS. ISI PERFORMED A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE AND FOUND THAT THERE WERE NO SYSTEM ERRORS GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS THAT THE PATIENT HAS EXPERIENCED. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT'S REPORT OF INJURY DURING A DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE. BASED ON THE INFORMATION PROVIDED, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT SINCE NO OTHER INFORMATION WAS PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI RIGHT SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR RIGHT OVARIAN CYSTIC MASS, AND INCREASING ABDOMINAL PAIN. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED POST-OPERATIVE REPORTS, PATHOLOGY REPORTS, AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THERE WAS A REPORT OF AN INTRA-OPERATIVE COMPLICATION, NAMELY AN AREA OF DESEROSALIZATION INVOLVING 1 PLACE ON THE BOWEL. THE OPERATION WAS OTHERWISE CHARACTERIZED BY EXTENSIVE LYSIS OF ADHESIONS OF THE LARGE AND SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL. THE OVARIAN CYST WAS REMOVED AND PROVED TO BE A PRE-MALIGNANT TUMOR. THERE WAS A SINGLE AREA ON THE BOWEL WHERE THE SEROSA WAS DISTURBED AND 2 SIMPLE SUTURES OF 3-0 CHROMIC WERE USED TO CLOSE THE DEFECT. THERE WAS A SMALL VAGINAL LACERATION CAUSED BY A SPONGE STICK USED TO HELP DELINEATE THE VAGINA. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2012, HE PATIENT TOLD HER PHYSICIAN THAT SHE WAS HAVING PROBLEMS WITH HER RECTUM ALONG WITH VAGINAL AND ANAL ITCHING. HER EXAM WAS NORMAL. SHE WAS PRESCRIBED HORMONAL CREAM. ON (B)(6) 2013, THE PATIENT REPORTED TO HER PHYSICIAN THAT SHE WAS HAVING ISSUES WITH ABDOMINAL PAIN AND BURNING ON URINATION. SHE WAS DESCRIBED AS BEING VERY ANGRY AND BELLIGERENT AT HAVING TO DEAL WITH HER VAGUE BUT ONGOING COMPLAINTS. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS PATIENT WITH SEVERE INTRABDOMINAL ADHESIONS FROM PRIOR SURGERY UNDERWENT A DA VINCI OOPHORECTOMY TO REMOVE A PRE-MALIGNANT TUMOR. SHE HAS HAD NO SIGNIFICANT INJURY WITH ANY CONSEQUENCES RELATED TO A MALFUNCTION OR DEFECT IN THE DA VINCI ROBOT. NOTABLY THIS PATIENT WAS NARCOTIC DEPENDENT AND SOME OF HER SYMPTOMS MAY BE RELATED TO CHRONIC CONSTIPATION, MORPHINE RELATED ITCHING , AND HER ATTITUDE AND BEHAVIOR MAY RELATED TO MENTAL HEALTH ISSUES AND DRUG DEPENDENCE. 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. 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

    ON (B)(6) 2013, INTUITIVE SURGICAL RECEIVED A TELEPHONE MESSAGE FROM A PATIENT WHO UNDERWENT A DA VINCI SI OVARIAN CYST REMOVAL PROCEDURE ON (B)(6) 2011. THE PATIENT REPORTED THAT DURING THE SURGICAL PROCEDURE SHE SUSTAINED INJURIES AND THAT POST-OPERATIVELY, SHE HAS CONTINUED TO EXPERIENCE PAIN. THE PATIENT INDICATED THAT SHE IS ONLY ABLE TO GET OUT OF BED TO GO TO THE HOSPITAL OR DOCTOR'S APPOINTMENTS. THE PATIENT UNDERWENT A POST-OPERATIVE CHECK UP WITH THE SURGEON; HOWEVER, SHE HAS NOT HAD ANY SUBSEQUENT CARE BY THE SURGEON SINCE THAT TIME. DURING A FOLLOW-UP WITH AN ASSOCIATE PHYSICIAN, THE PATIENT WAS TOLD THAT MORE DAMAGE WOULD OCCUR IF SHE UNDERWENT ANOTHER SURGICAL PROCEDURE. PER THE INFORMATION PROVIDED BY THE PATIENT, FOR THE LAST TWO YEARS SINCE THE SURGERY, SHE HAS NOT HAD A LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282569 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P4

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES