BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3306726 · Received August 26, 2013

    Report

    Report Number
    2955842-2013-03200
    Event Type
    Injury
    Date Received
    August 26, 2013
    Date of Event
    November 9, 2011
    Report Date
    July 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT ON JULY 25, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2011 DUE TO PELVIC PROLAPSE. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. IT WAS STATED IN THE OP REPORT THAT AFTER THE SURGICAL TASK OF SECURING THE PATIENT'S VAGINAL MESH WAS PERFORMED, EXCELLENT HEMOSTASIS WAS NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF LOWER ABDOMINAL PAIN AND SHOULDER PAIN. THE PATIENT UNDERWENT A DIAGNOSTIC TEST AND IT WAS DISCOVERED THAT SHE HAD A SMALL AMOUNT OF FREE AIR. A CHEST X-RAY WAS PERFORMED AND THE PATIENT BECAME PROGRESSIVELY WORSE IN HER SYMPTOMS. ON EXAMINATION, THE PATIENT WAS IN FAIRLY ACUTE DISTRESS. A CBC TEST SHOWED THAT THE PATIENT'S WHITE COUNT WAS 2900 AND HER HEMOGLOBIN WAS 10.7. FROM (B)(6) 2011 THROUGH (B)(6) 2011 THE PATIENT REMAINED HOSPITALIZED AND CONTINUED TO BE TREATED. ON (B)(6) 2011 THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. DURING THE LAPAROTOMY AN AREA OF DIVERTICULUM WITH A 4 TO 5 MM PERFORATION WAS DISCOVERED WITH FECAL CONTAMINATION. THERE WAS SOME EVIDENCE OF THERMAL EFFECT IN THE AREA OF THE PERFORATION. THE MESH WAS IN THE EXUDATE THAT WAS PRESENT. EXTENSIVE LAVAGE WAS CARRIED OUT AND THE REST OF THE PATIENT'S COLON AND SMALL BOWEL WERE INSPECTED. NO OTHER INJURIES WERE NOTED. THE AFFECTED AREA WAS DEBRIDED AND THE DEFECT WAS REPAIRED WITH SUTURES. THE MESH WAS REMOVED AND A TRANSVERSE COLOSTOMY WAS PERFORMED. A BLAKE DRAIN WAS PLACED IN THE PATIENT'S PELVIS AND IRRIGATION AND CLEANSING OF THE PARTICULATE MATTER AND CONTAMINATED LIQUID MATERIAL WAS REMOVED. A COLOSTOMY APPLIANCE WAS PLACED AND THE PATIENT WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE. ON (B)(6) 2011 THE PATIENT WAS DISCHARGED TO FOR REHABILITATION. THE PATIENT WAS DISCHARGED HOME FROM REHABILITATION ON (B)(6) 2011 IN A STABLE, ALERT, AND ORIENTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417060 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DA VINCI SI SURG INSTRUMENTS, ACCESSORIES & ESU