BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3843941 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03376
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE INSTRUMENT'S BLADES FAILED THE CUT TEST, BUT THE BLADES WERE NOT DAMAGED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM FOR LATEX CUT TEST AND THE SCISSORS DID NOT CUT CLEANLY THROUGH (B)(4) LATEX. THE LATEX GOT SNAGGED AT THE SCISSOR TIPS. THE BLADE EDGES WERE NOT DAMAGED, BUT EDGES EXHIBIT WEAR AT THE TIPS, WHICH NEGATIVELY AFFECTED CUT PERFORMANCE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S TUBE EXTENSION WAS CRACKED. THE TUBE EXTENSION WAS CRACKED AT ONE OF THE AXIAL KEYS, THERE WERE NO MISSING MATERIALS AND NO BROKEN PIECES WAS FOUND. EVIDENCE NOT CONCLUSIVE, BUT CRACKED DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT FLUSH TUBE WAS KINKED. THE HOUSING WAS REMOVED TO FIND FLUSH TUBE WITH A COUPLE OF KINKS IN THE BACKEND. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT, IN A FRAGMENT-CAUSING FAILURE (SUCH AS A CABLE FAILURE, A CRIMP SEPARATING FROM A CABLE ETC.) FOR THE MCS INSTRUMENT THE TIP COVER ACCESSORY WILL HOLD SUCH FRAGMENTS INSIDE THE TIP COVER, PREVENTING LOSS INTO THE PATIENT DURING THE REMOVAL OF THE INSTRUMENT. BECAUSE THE TIP COVER ACTS AS A BARRIER, THESE FAILURES, WHICH MIGHT BE REPORTABLE IN OTHER INSTRUMENTS, ARE NOT REPORTABLE EVENTS FOR THE MCS INSTRUMENT; HOWEVER, THE MAIN TUBE DAMAGE, WHICH WAS FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WOULD NOT WORK ANYMORE. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321448 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10130617 108

    Patients

    Seq Age Sex Outcome Treatment
    1