BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3895104 · Received June 25, 2014

    Report

    Report Number
    2955842-2014-03904
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    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 FOUND THE INSTRUMENTS TUBE EXTENSION WAS BROKEN NEAR THE PROXIMAL CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY WEAR. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN DAMAGE WAS LIKELY DUE TO MISHANDLING/ MISUSE. FAILURE ANALYSIS ALSO FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(4) 2014, A MEDWATCH FORM WAS RECEIVED BY INTUITIVE SURGICAL INC. (ISI) WITH THE FOLLOWING INFORMATION: SURGEON (GYNECOLOGIST) HAS BEEN USING MONOPOLAR CURVED SCISSORS FOR APPROXIMATELY 15 MINUTES WHEN THE SCISSORS BROKE AT THE JOINT. THEY WOULD NO STRAIGHTEN SO THAT THE INSTRUMENT COULD BE REMOVED FROM THE TROCAR IN PATIENT'S ABDOMEN. SURGEON SCRUBBED IN AND PHYSICALLY REMOVED INSTRUMENT AND TROCAR SIMULTANEOUSLY. NO HARM TO PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371866 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 N10140313 920

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR