BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3343086 · Received September 11, 2013

    Report

    Report Number
    2955842-2013-03482
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    July 6, 2012
    Report Date
    August 16, 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 INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF POST-SURGICAL COMPLICATIONS EXPERIENCED 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. ISI HAS CONTACTED RISK MANAGEMENT GROUP AT THE SITE TO GATHER ADDITIONAL INFORMATION; 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 EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S TRACHELECTOMY, HIGH UTEROSACRAL VAGINAL VAULT SUSPENSION, TRANSOBTURATOR SUBURETHRAL SLING AND A CYSTOSCOPY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF CERVICAL VAGINAL PROLAPSE, CERVICAL PAIN AND STRESS INCONTINENCE. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT, THE PATIENT HAS UNDERGONE A PREVIOUS HYSTERECTOMY PROCEDURE. THE PATIENT'S MEDICAL RECORDS REGARDING THIS PROCEDURE WERE NOT PROVIDED TO ISI. BASED ON THE INFORMATION IN THE PATIENT'S OP REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND IT WAS STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN EXCELLENT CONDITION. REPORTEDLY, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2012 COMPLAINING OF VAGINAL BLEEDING AND ABDOMINAL PAIN. THE PATIENT WAS TAKEN INTO THE OPERATING ROOM AND IT WAS DISCOVERED THAT THE PATIENT HAD A SMALL AMOUNT OF BLEEDING FROM THE VAGINAL CUFF. ACCORDING TO THE PATIENT'S OP REPORT, PATIENT'S VAGINAL CUFF WAS REPAIRED. THE AFFECTED AREA WAS CAUTERIZED AND SUTURED. HEMOSTASIS WAS NOTED TO BE EXCELLENT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN EXCELLENT CONDITION AND THERE WERE NO COMPLICATIONS. REPORTEDLY, POST-OPERATIVELY THE PATIENT WAS FOUND TO BE DOING WELL. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN EXCELLENT CONDITION ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456352 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU