BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3935524 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04289
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION WAS NOT ABLE TO VERIFY THE CUSTOMER REPORTED COMPLAINT. THERE WERE NO SPRINGS BROKEN ON THE INSTRUMENT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND A FRAYED PITCH DOWN CABLE AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI HYSTERECTOMY PROCEDURE, THE NURSE SAID A SPRING BROKE BUT THERE IS NOTHING VISUALLY DIFFERENT ABOUT THE INSTRUMENT. IT DIDN'T WORK PROPERLY SO THEY EXCHANGED IT FOR ANOTHER ONE. NO PATIENT INJURIES. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL CLARIFICATION REGARDING THE REPORTED COMPLAINT, WHO INDICATED THAT THE NURSE WROTE A NOTE THAT THE SPRING BROKE BUT WHEN HE EXAMINED THE INSTRUMENT, HE DID NOT SEE ANYTHING BROKEN AND THE CABLES WERE INTACT. THE INSTRUMENT DID NOT LOOK ANY DIFFERENT. HOWEVER, WHEN THEY INSTALLED THE INSTRUMENT, IT DID NOT WORK PROPERLY. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412635 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10140124 509

    Patients

    Seq Age Sex Outcome Treatment
    1