BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3388822 · Received October 4, 2013

    Report

    Report Number
    2955842-2013-04040
    Event Type
    Injury
    Date Received
    October 4, 2013
    Date of Event
    August 31, 2013
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE INFORMATION RECEIVED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. INTUITIVE SURGICAL INC. (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: A PATIENT'S ATTORNEY ALLEGES INJURIES INCLUDING BOWEL OBSTRUCTION, ABDOMINAL PAIN, AND THE NEED TO HAVE THE LARGE INTESTINE AND COLON REMOVED AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 4, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED THE OPERATIVE REPORT AND MEDICAL RECORDS FROM THE ATTORNEY REPRESENTING THE PATIENT WHO UNDERWENT A DA VINCI'S RADICAL PROSTATECTOMY WITH BILATERAL NERVE SPARING AND RIGHT PELVIC LYMPH NODE DISSECTION ON (B)(6) 2010. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PROSTATE CANCER. PRIOR TO THE PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS OF THE SURGERY AS WELL AS ALTERNATIVES. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT EXPRESSED UNDERSTANDING AND CONSENT WAS OBTAINED. BASED ON THE OPERATIVE REPORT, THERE WAS NO ALLEGATION OR INDICATION THAT A MALFUNCTION OF THE DA VINCI'S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA. THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE DISCHARGE SUMMARY, THE PATIENT DID WELL IN THE EARLY POSTOPERATIVE PERIOD WITH STABLE HEMATOCRITS AND CREATININE. THE PATIENT WAS DISCHARGED HOME ON POST-OP DAY 1. ON (B)(6) 2010, THE PATIENT PRESENTED TO AN EMERGENCY DEPARTMENT WITH COMPLAINTS OF 6 DAYS OF NAUSEA AND VOMITING. FOR A PERIOD OF TWO DAYS, THE PATIENT DENIED HAVING ANY BOWEL MOVEMENTS OR FLATUS. THAT SAME DAY, THE PATIENT UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS, AS WELL AS A CHEST X-RAY. THE CT SCAN REVEALED A HIGH-GRADE DISTAL SMALL BOWEL OBSTRUCTION. ON (B)(6) 2010, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AS WELL AS DRAINAGE OF INTRA-ABDOMINAL FLUID. DURING THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL BOWEL OBSTRUCTION, INTERNAL HERNIA IN THE LEFT UPPER QUADRANT, AND A SMALL BOWEL PERFORATION. THE SURGEON RESECTED A 5 CM PORTION OF THE SMALL BOWEL WHERE AN AREA OF BILIOUS ENTERIC CONTENTS WAS IDENTIFIED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE PACU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD CONDITION ON SEPTEMBER 15, 2010. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2010, AND ALLEGED TO HAVE INJURIES INCLUDING BOWEL OBSTRUCTION AND ABDOMINAL PAIN. IT WAS ALSO ALLEGED THAT THE PATIENT'S LARGE INTESTINE AND COLON WERE REMOVED DUE TO INVOLUNTARY ACCIDENTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503880 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE