BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOT SHEARS (TM) (MONOPOLAR CUR

    MDR report key: 3122201 · Received May 21, 2013

    Report

    Report Number
    2955842-2013-01764
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 15, 2012
    Report Date
    April 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2013, THE REPORTER CONTACTED ISI AND MENTIONED THAT FRAGMENTS DID NOT FALL INTO THE PATIENT AS INITIALLY INDICATED IN THE INITIAL REPORT THAT WAS SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AND IS BEING REQUESTED BACK FOR INVESTIGATION. THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE REPORTER SEVERAL TIMES VIA EMAIL AND HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE REPORTER TO ANSWER ANY ADDITIONAL QUESTIONS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE COMPLAINT IS BEING REPORTED BASED ON THE INITIAL INFORMATION THAT WAS PROVIDED TO INTUITIVE SURGICAL INC.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, THE TUBE EXTENSION OF THE MCS INSTRUMENT WAS RETURNED AND EVALUATED. IT WAS NOTED THAT THE TUBE EXTENSION WAS BROKEN AND MISSING A .350 X .275 PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM THE TUBE EXTENSION. THE TUBE EXTENSION WAS FOUND TO BE FRACTURED NEXT TO ONE OF THE KEYS THAT MATES WITH THE PROXIMAL CLEVIS. ENGINEERING EVALUATION CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING/MISUSE. ELECTRICAL CONTINUITY TESTING OF THE INSTRUMENT PASSED. NO OTHER DAMAGE WAS FOUND ON THE DEVICE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE MONOPOLAR CURVED SCISSORS BROKE OFF DURING A PROSTATECTOMY PROCEDURE AND FELL INTO THE PATIENT. THE BROKEN TIP WAS RETRIEVED AND THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO THE ALLEGED ISSUE. THE SURGERY WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224825 HOT SHEARS (TM) (MONOPOLAR CUR ENDOSCOPIC ELECTROSURGICAL NAY INTUITIVE SURGICAL,INC. 420179-10 M11110822 548

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU