BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3444182 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04936
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    September 21, 2012
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) SPOKE WITH THE SITE'S DIRECTOR OF RISK MANAGEMENT. SHE INDICATED THAT THE SITE DOES NOT HAVE ANY REPORTS OF ANY ISSUES OR MALFUNCTIONS OF THE DA VINCI SURGICAL SYSTEM RELATED TO THE DA VINCI HYSTERECTOMY SURGERY THAT WAS PERFORMED ON (B)(6) 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS STILL BEING REPORTED BASED ON THE INITIAL COMPLAINT: THE PATIENT ALLEGEDLY EXPERIENCED POST SURGICAL COMPLICATIONS AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND ADHESIOLYSIS FOR PELVIC PAIN, OVARIAN CYST, AND MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (B)(6) 2012. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER TRANSVAGINAL PLACEMENT OF THE RUMI AND CREATION OF A PNEUMOPERITONEUM WITH A TRANSUMBILICALLY INSERTED VERESS NEEDLE, 5 PORTS WERE INSERTED INTO THE ABDOMEN (FOUR UNDER DIRECT VISUALIZATION) AND THE ROBOT WAS DOCKED. ON INITIAL INSPECTION, ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL WERE FOUND, WHICH WERE TAKEN DOWN WITH SHARP DISSECTION, AS WELL AS ELECTROCAUTERY. THE INSPECTION REVEALED GOOD URETERS. BILATERAL LATERAL LIGAMENTS FROM THE UTERUS TO THE PELVIS WERE BURNED WITH THE PK AND CUT; THE BLADDER FLAP COMPLETED AND DISSECTED OF THE UTERUS, THE UTERINE VESSELS CLAMPED AND BURNED AND THEN AN ANTERIOR AND POSTERIOR COLPOTOMY PERFORMED. BOTH COLPOTOMIES WERE COMPLETED BILATERALLY WITH SCISSORS. THE UTERUS WAS REMOVED THROUGH THE VAGINAL CUFF. A V-LOC SUTURE PLACED IN THE RIGHT ANGLE OF THE CUFF, SECURED, AND THEN RUN FROM THE RIGHT TO THE LEFT DOING ANTERIOR-POSTERIOR CUFF TOGETHER, AND THEN AFTER LEFT ANGLE, SECURED, BROUGHT TO MIDLINE, AND CUT. FLOSEAL WAS PLACED. FINAL CYSTOSCOPY REVEALED A NORMAL DOME OF THE BLADDER AND FILL AND SPILL OF INDIGO FROM BOTH URETER SITES. ON (B)(6) 2012 THE PATIENT PRESENTS WITH SOME FEVER, NAUSEA, AND ABDOMINO-PELVIC PAIN. A CT OF HER ABDOMEN AND PELVIS REVEALED A 9.1 X 7.7 CM COLLECTION AND THE INDICATION FOR A TRANSVAGINAL REVISION AND DRAINAGE OF THE COLLECTION WAS MADE. ON (B)(6) 2012 200 ML OF OLD BLOOD COMING FROM HER VAGINAL CUFF WAS DRAINED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THIS OPERATIVE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563010 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES