BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4182250 · Received October 17, 2014

    Report

    Report Number
    2955842-2014-05504
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT'S AUTOPSY WAS PERFORMED BY THE STATE AND THE RESULTS WERE RECENTLY PROVIDED. THE ROBOTICS COORDINATOR INDICATED THAT THE AUTOPSY REPORT REVEALED A SMALL BOWEL PERFORATION. THE EXACT LOCATION AND DESCRIPTION OF THE BOWEL INJURY WAS NOT PROVIDED. HOWEVER, THE ROBOTICS COORDINATOR STATED THAT THE BOWEL INJURY WAS CAUSED BY USER-ERROR AND NOT A MALFUNCTION OF A DA VINCI INSTRUMENT. THE ROBOTICS COORDINATOR INDICATED THAT THE SITE IS UNSURE IF THE BOWEL INJURY OCCURRED DURING CREATION OR INITIAL ENTRY INTO THE SINGLE-SITE PORT. THE CAUSE OF THE PATIENT'S DEATH WAS NOT PROVIDED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT PASSED AWAY 1 DAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. DURING THE SURGICAL PROCEDURE, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE SURGEON WAS HAVING ISSUES WITH CLIPS DISLODGING FROM A SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT DURING INSERTION THROUGH A CANNULA. TOWARDS THE END OF THE SURGICAL PROCEDURE, A CLIP INSTALLED ON THE SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FELL INSIDE THE PATIENT. THE SURGEON SPENT ABOUT 10 MINUTES SEARCHING FOR THE CLIP USING A SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT AND A SINGLE-SITE CROCODILE GRASPER INSTRUMENT. DURING THE PROCESS OF SEARCHING FOR THE CLIP, THE SURGEON LACERATED THE LOWER LOBE OF THE PATIENT'S LIVER AS HE WAS MANIPULATING OR LIFTING THE ORGAN WITH THE SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY CAUTERIZING THE LACERATION. THE SURGEON THEN PROCEEDED TO COMPLETE THE DA VINCI SURGICAL PROCEDURE. PRIOR TO COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT ALSO UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AND UNSPECIFIED HERNIA REPAIR PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WOKE UP AGGRESSIVELY WHILE IN RECOVERY AND HAD COMPLAINTS OF ABDOMINAL PAIN. APPROXIMATELY 5 HOURS POST-OPERATIVELY, A CT-SCAN WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE EXTENSIVE FREE AIR IN HIS ABDOMEN. THE PATIENT PASSED AWAY EARLY THE NEXT DAY IN THE MORNING. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT'S FAMILY DECLINED TO HAVE AN AUTOPSY PERFORMED BY THE HOSPITAL. INSTEAD, THE PATIENT'S FAMILY REQUESTED FOR AN AUTOPSY TO BE PERFORMED BY THE STATE CRIME LAB. THE ROBOTICS COORDINATOR INDICATED THAT THE AUTOPSY HAS BEEN COMPLETED; HOWEVER, THE AUTOPSY RESULTS ARE PENDING RELEASE. THE ROBOTICS COORDINATOR CONFIRMED THAT THE SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT DID NOT MALFUNCTION DURING THE TIME THAT THE PATIENT'S LIVER INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661656 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death