BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3470539 · Received November 14, 2013

    Report

    Report Number
    2955842-2013-05206
    Event Type
    Injury
    Date Received
    November 14, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S BOWEL INJURY. ACCORDING TO THE SITE'S RM, THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE SYSTEM AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT THAT WAS USED DURING THE SURGICAL PROCEDURE WERE EVALUATED BY THE FSE AND THE REPORTED ISSUE OF BIPOLAR FIRING ON IT'S OWN COULD NOT BE REPLICATED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A PERFORATED BOWEL INJURY AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S BOWEL INJURY IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY. THE PATIENT UNDERWENT REPAIR OF THE BOWEL INJURY BY GENERAL SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGER (RM) FROM THE SITE. THE RM REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY DOCUMENTATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THERE ALSO WAS NO REPORT THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED DURING THE PROCEDURE. BASED ON THE RM'S REVIEW OF THE PATIENT'S MEDICAL RECORDS, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 WITH REPORTED COMPLAINTS OF ABDOMINAL PAIN. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO EVALUATE A SUSPECTED PELVIC ABSCESS. THE FOLLOWING DAY ON (B)(6) 2013, THE PATIENT UNDERWENT REPAIR OF A PERFORATED BOWEL. ALSO, ON (B)(6) 2013, THE PATIENT UNDERWENT A SMALL BOWEL RESECTION PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH A COLOSTOMY ON (B)(6) 2013. DURING THE COURSE OF THE HOSPITALIZATION, THE PATIENT WAS REPORTEDLY TREATED FOR SEPSIS. THE RM DID NOT KNOW THE PATIENT'S CURRENT STATUS. SOMETIME AFTER (B)(6) 2013, THE RM SPOKE TO THE SURGICAL STAFF INVOLVED WITH THE DA VINCI HYSTERECTOMY PROCEDURE. ACCORDING TO THE RM, THE SURGEON INFORMED HER THAT IT WAS HER BELIEF THAT THE PATIENT'S BOWEL INJURY WAS POSSIBLY CAUSED BY ARCING. HOWEVER, THE SURGEON AND SURGICAL STAFF INDICATED THAT THEY DID NOT SEE ANY EVIDENCE OF ARCING DURING THE SURGICAL PROCEDURE. THE RM STATED THAT THE SURGICAL STAFF ALSO INDICATED THAT THE SURGEON REPORTEDLY EXPERIENCED BIPOLAR FIRING ON ITS OWN DURING THE DA VINCI SURGICAL PROCEDURE AND A SUBSEQUENT PROCEDURE PERFORMED ON (B)(6) 2013 WITH THE SAME INSTRUMENT. HOWEVER, THE RM REITERATED THAT THE OPERATIVE REPORT FOR (B)(6) 2013 DID NOT SHOW ANY REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, A COMPLAINT WAS CREATED FOR THE EVENT THAT OCCURRED ON (B)(6) 2013 ALTHOUGH THERE WAS NO REPORT THAT A PATIENT INJURY OCCURRED DURING THE PROCEDURE. ON (B)(6) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THROUGH TROUBLESHOOTING, THE FSE WAS UNABLE TO REPLICATE THE REPORTED BIPOLAR FIRING ON ITS OWN ISSUE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT USED DURING THE PROCEDURES PERFORMED ON (B)(6) 2013 AND (B)(6) 2013. THE SITE'S BIO TECHS ALSO ANALYZED THE SYSTEM'S GENERATOR AND NO ISSUES WERE FOUND. THE FSE TESTED THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ON (B)(6) 2013, ISI SPOKE TO THE FSE DIRECTLY. THE FSE STATED THAT THE SITE DID NOT MENTION THAT AN ISSUE OCCURRED DURING THE DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013. HE ALSO STATED THAT HE DID NOT OBSERVE ANY EVIDENCE OF ARCING ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT USED DURING THE PROCEDURES PERFORMED ON (B)(6) 2013 AND (B)(6) 2013 WHEN TROUBLESHOOTING THE INSTRUMENT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589935 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R