BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 2252309 · Received September 17, 2011

    Report

    Report Number
    2955842-2011-00301
    Event Type
    Other
    Date Received
    September 17, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH A PATIENT SIDE MANIPULATOR (PSM). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION OBSERVED THAT THE AXIS 2 ROLLING LOOP WAS DEFORMED CAUSING INTERFERENCE AND BINDING OF THE CABLE FOR INSERTION. THE ROLLING LOOP WAS REPLACED TO RESOLVE THE ISSUE WITH THE PSM. AS OF (B)(6), 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED DIFFICULTY WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM NOT RECOGNIZING THE INSTRUMENT CANNULA ACCESSORY. THE SITE ATTEMPTED TO TROUBLESHOOT THE PROBLEM WITHOUT SUCCESS. AT THIS TIME, THE PATIENT HAD BEEN UNDER ANESTHESIA AND THE PORT HOLES HAD BEEN CREATED WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULE TO A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES