BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 2890256 · Received December 28, 2012

    Report

    Report Number
    2955842-2012-01473
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE CASING WAS COMING OFF. COMPLAINT OF INSTRUMENT NOT GRASPING PROPERLY WAS NOT CONFIRMED. THE MAIN TUBE INSULATION APPEARS TO HAVE SCRATCHES AND GOUGE MARKS, WITH MATERIALS REMOVED AT THE DISTAL END. EVIDENCE WAS NOT CONCLUSIVE, BUT DAMAGE IS LIKELY CAUSED BY EXCESS FORCE CONTACT ON THE MAIN TUBE SURFACE. THE INSTRUMENT HAS 15 USES REMAINING. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. BASED ON THIS, NO ADDITIONAL FOLLOW UP IS REQUIRED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS 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 INTRAOPERATIVE. 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 DURING A DA VINCI S SURGICAL PROCEDURE, THE BOWEL GRASPER INSTRUMENT WAS NOT GRASPING PROPERLY AND BLACK MATERIAL IS PEELING OFF THE SHAFT. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOWEL GRASPER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-04 S10110519 385

    Patients

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