BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3790804 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02767
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT BLADES WERE BENT. THE INSTRUMENT WAS PLACED ON AN IN HOUSE SYSTEM AND THERE WAS TROUBLE CLOSING THE GRIPS. ONE OF THE BLADES WAS BENT BACK AND DID NOT ALLOW THE BLADES TO CLOSE PROPERLY. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE WAS LIKELY DUE TO MISHANDLING AND MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENTS TUBE EXTENSIONS PAD PRINTING WAS REMOVED. THERE WAS PAD PRINTING REMOVED IN TWO AREAS MEASURING ABOUT .095 AND THE OTHER MEASURING ABOUT .047. THE TUBE EXTENSION WAS BENT IN BETWEEN THE TWO AREAS MISSING THE PAD PRINTING. THE BENT DAMAGE WAS LOCATED WHERE ONE OF THE TUBE EXTENSION TEETH MEETS WITH THE DISTAL CLEVIS HUB. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING THAT WAS REMOVED WAS DUE TO MISHANDLING AND MISUSE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, IT WAS NOTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD STOPPED WORKING CORRECTLY. THE INSTRUMENT COULD NOT BE CLOSED. INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT TO CONFIRM IF ANY FRAGMENTS FELL INTO A PATIENT OR IF THERE WERE ANY REPORT OF PATIENT INJURY OR HARM HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT OF THE SAME TYPE. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267210 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10131210 413

    Patients

    Seq Age Sex Outcome Treatment
    1