BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2993400 · Received March 7, 2013

    Report

    Report Number
    2955842-2013-00764
    Event Type
    Other
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISI CLINICAL SALES REPRESENTATIVE INDICATED THAT THE SURGEON EXPERIENCED A PROBLEM DUE TO A BROKEN CABLE LOCATED ON THE BACK OF THE DA VINCI SI SURGICAL SYSTEM PATIENT SIDE MANIPULATOR (PSM) ARM 1 RESULTING IN THE SURGEON NOT ABLE TO ADVANCE THE MONOPOLAR CURVED SCISSOR'S INSTRUMENT INTO THE PATIENT. THE SURGICAL STAFF MOVED THE MONOPOLAR CURVED SCISSOR'S INSTRUMENT FROM PSM ARM 1 TO PSM ARM 3 TO CONTINUE WITH THE PROCEDURE. AS THE SURGEON CONTINUED WITH THE PROCEDURE A HOLE WAS DISCOVERED TO HAVE BEEN MADE IN THE PATIENT'S BLADDER AND THE SURGEON MADE THE DECISION TO CONVERT THE CASE TO TRADITIONAL OPEN SURGERY TO REPAIR THE BLADDER. THE CASE WAS COMPLETED WITH NO FURTHER HARM TO THE PATIENT, THE PATIENT STATUS WAS STABLE FOLLOWING THE PROCEDURE. THE ISI FIELD SERVICE ENGINEER VISITED THE ACCOUNT THE FOLLOWING DAY TO REPAIR THE PATIENT SIDE MANIPULATOR (PSM) ARM. AS OF THE DATE OF THIS REPORT, NO FURTHER RELATED INCIDENTS HAVE OCCURRED. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Additional Manufacturer Narrative · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION (OPERATIVE REPORT AND DISCHARGE SUMMARY DOCUMENTS) REGARDING THE DA VINCI HYSTERECTOMY PROCEDURE THAT TOOK PLACE ON (B)(6) 2013. ACCORDING TO THE OPERATIVE REPORT, THE ROBOTIC-ASSISTED LAPAROSCOPIC VAGINAL HYSTERECTOMY WAS CONVERTED TO TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY. IT WAS ALSO NOTED THAT A REPAIR OF CYSTOTOMY, AND REIMPLANTATION OF THE PATIENT'S LEFT URETER WERE ALSO PERFORMED. THE OPERATIVE REPORT INDICATED ...BLEEDING WAS ENCOUNTERED, AND AN INCIDENTAL CYSTOTOMY WAS RECOGNIZED. THE 1 ARM OF THE DA VINCI ROBOT BECAME NONFUNCTIONAL. THE ROBOTIC PROCEDURE WAS THEN ABANDONED AND CONVERTED TO A TOTAL ABDOMINAL HYSTERECTOMY. THERE WERE NO SPECIFIC DETAILS AS TO HOW THE DA VINCI ROBOT BECAME NON FUNCTIONAL IN THE OPERATIVE REPORT AND IT IS NOT CLEAR IF THE DA VINCI SYSTEM BECAME NONFUNCTIONAL BEFORE OR AFTER THE CYSTOTOMY WAS IDENTIFIED; HOWEVER, WHEN ISI SPOKE WITH THE SITE'S CLINICAL SALES REPRESENTATIVE (CSR) ON (B)(6) 2013 (REPORTED ON INITIAL MDR THAT WAS SUBMITTED ON 03/07/2013), IT WAS REPORTED THAT THE SITE HAD ENCOUNTERED THE ISSUE WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 DUE TO A BROKEN CABLE ON THE PSM 1 ARM SO THE SURGICAL STAFF MOVED THE MCS INSTRUMENT FROM PSM ARM 1 TO PSM ARM 3 TO CONTINUE WITH THE PROCEDURE. AS THE SURGEON CONTINUED THE PROCEDURE, A HOLE WAS DISCOVERED IN THE PATIENT'S BLADDER AND THE SURGEON MADE THE DECISION TO CONVERT TO AN OPEN SURGICAL PROCEDURE. THE PATIENT'S DISCHARGE SUMMARY REFERENCED THE ABORTED ROBOTIC PROCEDURE WHERE THE 2 ARM GUIDING THE MONOPOLAR CURVED SCISSORS MALFUNCTIONED, AND AN INCIDENTAL CYSTOMY WAS SUSTAINED. FOLLOWING COMPLETION OF THE ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, THE INCIDENTAL CYSTOTOMY WAS REPAIRED AND THERE WAS AN REIMPLANTATION OF THE URETER. THE PATIENT ALSO RECEIVED A FOLEY CATHETER, WHICH WAS REMOVED ON DAY 3. THE PATIENT WAS DISCHARGED ON DAY 5 ((B)(6) 2013). IT WAS INITIALLY REPORTED BY THE SITE'S CSR THAT THE CONVERSION TO OPEN SURGERY WAS NOT RELATED TO THE PSM ARM ISSUE. IN ADDITION, THERE IS NO ALLEGATION IN THE MEDICAL RECORDS THAT INDICATES THAT THE REPORTED ISSUE WITH THE PSM 1 AND THE MCS INSTRUMENT CONTRIBUTED TO THE PATIENT'S INCIDENTAL CYSTOTOMY AND THE CONVERSION TO OPEN SURGERY. HOWEVER, THIS COMPLAINT REMAINS REPORTABLE BECAUSE INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT AND BECAUSE THE DA VINCI SURGERY WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR'S INSTRUMENT LOCATED ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 FAILED. THE CUSTOMER CONTACTED ISI TECHNICAL SUPPORT HOWEVER DUE TO ISSUES UNRELATED TO DA VINCI SI SURGICAL SYSTEM, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97401 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES