BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED SCISSORS

    MDR report key: 2895886 · Received January 3, 2013

    Report

    Report Number
    2955842-2013-00051
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND DRIVEN. RECOGNITION AND ENGAGEMENT PASSED. THE SNAKE WRIST WAS YAWED OVER TO ONE SIDE INSTEAD OF STRAIGHT WHEN FIRST INSTALLED. HOUSING WAS REMOVED TO FIND INPUT GEARS FOR PITCH AND YAW HAVE SKIPPED SOME TEETH. SKIPPED TEETH CHANGE THE ORIENTATION OF THE SNAKE WRIST. BLADES WOULD NOT OPEN AS WELL, AS THEY ARE STUCK. ADDITIONAL OBSERVATION NOT REPORTED WAS DAMAGE TO THE MAIN TUBE. INSULATION WAS FOUND WITH SEVERAL GOUGE MARKS. MARKS WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. THE MAIN TUBE ALSO EXHIBITED A COUPLE OF DIFFERENT DAMAGED SECTIONS WITH TUBE INSULATION REMOVED, AND MATERIAL IS MISSING. THE MAIN TUBE ALSO EXHIBITS DISCOLORATION (WHITE STRIATIONS). EVIDENCE NOT CONCLUSIVE, BUT DAMAGE MAY BE A RESULT OF IMPROPER CLEANING. THE INSTRUMENT HAS 6 USES LEFT. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF PERTINENT ADDITIONAL INFORMATION IS RECEIVED. 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 CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SCISSOR TIPS ON THE CURVED SCISSORS INSTRUMENT WOULD NOT OPEN. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3741 CURVED SCISSORS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420146-04 S10081106 546

    Patients

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