BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2781669 · Received October 10, 2012

    Report

    Report Number
    2955842-2012-00532
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    May 24, 2012
    Report Date
    January 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. CUSTOMER INITIALLY REPORTED FAULTY INSTRUMENT. HOWEVER FOR CLARIFICATION, THE DEFECT WAS A BROKEN PITCH CABLE. THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. IDLER PULLEY WAS FOUND TO BE PHYSICALLY DAMAGED. IDLER PULLEY EXHIBITED INDENTATIONS AND RIDGES INDICATIVE OF MISHANDLING AND MAY HAVE CAUSED PITCH CABLE TO BREAK. TUBE INSULATION ALSO APPEARS TO HAVE SCRATCHES AND GOUGE MARKS WITH THE SURFACE REMOVED. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE IS LIKELY CAUSED BY MISHANDLING/MISUSE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: - PROPER CARE AND HANDLING IS ESSENTIAL FOR SATISFACTORY PERFORMANCE OF SURGICAL INSTRUMENTS AND ACCESSORIES. EXAMINE THE INSTRUMENT OR ACCESSORY - INCLUDING ALL OF ITS COMPONENTS - THOROUGHLY BEFORE AND AFTER EACH USE. IF ANY ABNORMALITY IS FOUND, DO NOT USE IT. USE THE DEVICE FOR ITS INTENDED PURPOSE ONLY. - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. - DO NOT USED A DAMAGED CANNULA OR REDUCER. DAMAGED CANNULAE AND REDUCERS MAY ABRADE THE INSTRUMENT SHAFT AND GENERATE PARTICLES THAT MAY FALL INSIDE THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND FAULTY. THE INSTRUMENT WAS REPLACED WITH ANOTHER MARYLAND BIPOLAR FORCEPS INSTRUMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2012 ISI RECEIVED ADDITIONAL INFORMATION INDICATING A PATIENT X-RAY WAS PERFORMED POST OPERATIVELY. THE X-RAY SHOWED NO FOREIGN BODY AND THE PATIENT DID NOT DEVELOP ANY COMPLICATIONS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110706 942

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other DA VINCI SI SURG SYSTEM, INSTRUMENTS & ACCESSORIE