BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2781479 · Received October 10, 2012

    Report

    Report Number
    2955842-2012-00521
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, ISI CONTACTED DR. (B)(6), A NEURO-OPHTHALMOLOGIST, WHO WAS REFERENCED AS ONE OF THE AUTHORS OF THE ARTICLE AND HE INDICATED THE PATIENT UNDERWENT THE A DA VINCI PROSTATECTOMY PROCEDURE OVER 5 YEARS AGO AT (B)(6). DR. (B)(6) INDICATED THAT HE DID NOT RECALL THE NAME OF THE PATIENT'S UROLOGIST AND ADVISED ME TO CONTACT DR. (B)(6), WHO WAS ALSO REFERENCED AS AN AUTHOR IN THE ARTICLE. ON (B)(6) 2012, ISI RECEIVED AN EMAIL RESPONSE FROM DR. (B)(6) AND HE INDICATED THAT HE WAS NOT THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE AND THAT HE NO LONGER HAS THE PATIENT'S RECORDS AND HE IS UNABLE TO PROVIDE INFORMATION CONCERNING THE PATIENT WITHOUT THE PATIENT'S CONSENT. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, AN ARTICLE TITLED POSTERIOR ISCHEMIC OPTIC NEUROPATHY AFTER MINIMALLY INVASIVE PROSTATECTOMY PUBLISHED IN J NEURO-OPHTHALMOL, VOL 27, NO 4, 2007 WAS REVIEWED BY AN ISI CLINICAL PROJECT MANAGER. PER THE INFORMATION IN THE ARTICLE, POST OP A DA VINCI PROSTATECTOMY PROCEDURE THE PATIENT COMPLAINED OF PURPLE VISION AND LOSS OF INFERIOR VISUAL FIELDS IN BOTH EYES. THE ARTICLE INDICATES THAT THE PATIENT'S SYMPTOMS WORSENED WHEN HE WAS UPRIGHT AND ON THE SAME DAY A NEURO-OPHTHALMOLOGIST RECORDED VISUAL ACUITIES OF 20/25 IN BOTH OF THE PATIENT'S EYES. THE ARTICLE INDICATES THAT THE PATIENT DID NOT HAVE FACIAL EDEMA AND THE OPTIC DISCS WERE DESCRIBED AS OF NORMAL APPEARANCE WITH A CUP/DISC RATIO OF 0.25. THE ARTICLE ALSO INDICATED THAT AUTOMATED HUMPHREY VISUAL FIELDS DEMONSTRATED BILATERAL INFERIOR ALTITUDINAL DEFECTS AND THE PATIENT'S HEMOGLOBIN LEVEL WAS 9.7 G/DL. THE ARTICLE INDICATES THAT THE PATIENT'S BLOOD PRESSURE AND PULSE WERE NORMAL. THE ARTICLE INDICATES THAT THE RESULTS OF PREOPERATIVE LABORATORY STUDIES PERFORMED 1 WEEK BEFORE THE PROCEDURE WERE ALL WITHIN NORMAL RANGES, WITH HEMOGLOBIN OF 14.2 G/DL AND THAT THE PATIENT'S BLOOD PRESSURE ON THE MORNING OF THE SURGERY WAS 127/66 MM HG, AND THE PATIENT HAD NO HISTORY OF HYPERTENSION. THE ARTICLE INDICATES THAT SHORTLY AFTER INDUCTION OF ANESTHESIA, THE PATIENT BECAME HYPOTENSIVE (90/45 MM HG) FOR ABOUT 1 HOUR WITH A NADIR OF 85/33 MM HG. THE ARTICLE INDICATES THAT NO BLOOD LOSS OCCURRED. THE ARTICLE INDICATES THE FOLLOWING CONCERNING THE SURGICAL PROCEDURE: THE PATIENT WAS THEN PLACED INTO A STEEP TRENDELENBURG TILT IN A LOW LITHOTOMY POSITION. THE TOTAL OPERATIVE TIME WAS 6 HOURS 35 MINUTES, AND FOR >5 HOURS, THE BLOOD PRESSURES WERE MAINTAINED IN A RANGE OF 90-135 MM HG SYSTOLIC AND 50-95 MM HG DIASTOLIC. MULTIPLE INTRAOPERATIVE HEMOGLOBIN MEASUREMENTS RANGED FROM 8.2 TO 11.9 G/DL. APPROXIMATELY 4 HOURS INTO THE PROCEDURE, AFTER THE PATIENT HAD RECEIVED 4,300 ML OF LACTATED RINGER'S SOLUTION AND HAD LOST APPROXIMATELY 550 ML OF BLOOD, T HE PATIENT WAS GIVEN A TRANSFUSION OF 1 UNIT OF PACKED RED BLOOD CELLS. THE PROCEDURE WAS PROLONGED BY THE LOSS OF ONE NEEDLE DURING BLADDER REPAIR BUT CONCLUDED UNEVENTFULLY. TOTAL BLOOD LOSS WAS 1,200 ML. THE ARTICLE INDICATES THAT THE PATIENT WAS OBSERVED FOR 3 DAYS AND DISCHARGED, DURING WHICH TIME THE PATIENT'S VISION REMAINED UNCHANGED. THE ARTICLE FURTHER INDICATES THAT AT A FOLLOW UP EXAMINATION PERFORMED 3 MONTHS LATER, FOUND THAT THE PATIENT'S VISUAL ACUITIES WERE 20/20 IN BOTH EYES, AND A VISUAL FIELD EXAMINATION CONFIRMED STABLE LOSS OF BILATERAL INFERIOR FIELDS. THE ARTICLE INDICATES THAT AN OPHTHALMOSCOPY PERFORMED DISCLOSED BILATERAL SUPEROTEMPORAL OPTIC DISC PALLOR. THE ARTICLE INDICATES THAT THE PATIENT LOST VISION INFERIORLY, HOWEVER THE PATIENT RETAINED GOOD FOVEAL FUNCTION WITH 20/20 VISION. THE ARTICLE ALLEGES THAT PROLONGED OPERATIVE TIME AND TRENDELENBURG POSITIONING OF THE PATIENT MAY HAVE PLAYED A CAUSATIVE ROLE IN THE ISCHEMIC OPTIC NEUROPATHY DEVELOPED BY THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other DA VINCI SURGICAL SYSTEM INSTRUMENT & ACCESSORIES