BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3440710 · Received October 31, 2013

    Report

    Report Number
    2955842-2013-04799
    Event Type
    Injury
    Date Received
    October 31, 2013
    Date of Event
    April 26, 2013
    Report Date
    October 1, 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 THE INJURY AND SUBSEQUENT 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. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BLADDER PERFORATION DURING A DA VINCI S PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION PROCEDURE AND EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION FOR ADENOCARCINOMA OF THE PROSTATE ON (B)(6) 2013. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES THE PATIENT'S SECONDARY ADMISSION FOR SEPSIS AND DISCHARGE SUMMARY. IN THE PRIMARY SURGERY, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AFTER ENTRY AND INSPECTION, THE DISTAL PERITONEUM WAS TAKEN DOWN, THE VAS DEFERENS, TRANSECTED, THE SEMINAL VESICLE DISSECTED FREE USING CLIPS AND SHARP DISSECTION. THE ANTERIOR BLADDER FLAP WAS CREATED, THE DORSAL VEIN COMPLEX SUTURED, AND THE NEUROVASCULAR BUNDLES SPARED USING CLIPS AND SHARP DISSECTION. THE URETHRA WAS TAKEN WITH CAUTERY. THE RECONSTRUCTION WAS INITIALLY CREATED, BUT HAD TO BE REDONE AS IT HAD BEEN DISRUPTED. AFTER THE ANASTOMOSIS WAS REDONE, THE BLADDER WAS TESTED AND THE ANASTOMOSIS WAS NOTED TO BE WATER TIGHT. THEN BILATERAL PELVIC LYMPH NODE DISSECTION WAS PERFORMED WITH SCISSORS AND CAUTERY. THE WOUNDS WERE CLOSED AND THE PROCEDURE COMPLETED WITH NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT'S POST-OPERATIVE COURSE WAS COMPLICATED WITH ACUTE RENAL FAILURE, HYPERKALEMIA AND A PERFORATED BLADDER FOR WHICH HE RECEIVED BILATERAL NEPHROSTOMY TUBES AND WAS PLACED ON ANTIBIOTICS. THE DISCHARGE SUMMARY WAS NOT PROVIDED TO ISI. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE ER WITH FEVER OF THREE DAYS DURATION AND DIFFUSE ABDOMINAL PAIN WITH TEA COLORED FLUID DRAINING FROM THE NEPHROSTOMY TUBES. URINALYSIS SHOWED PYURIA AND BACTERIURIA. THE PATIENT WAS DIAGNOSED WITH SEPSIS SECONDARY TO UTI AND TRANSAMINITIS OF AN UNKNOWN ORIGIN. HE WAS ADMITTED INTO THE HOSPITAL AND PLACED ON ANTIBIOTICS. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2013. NO FURTHER HISTORY AFTER DISCHARGE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559205 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R DAV S SURGICAL SYS INSTRUMENTS, ACCESSORIES & ESU