BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3243596 · Received July 23, 2013

    Report

    Report Number
    2955842-2013-02693
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH THE TUBE EXTENSION MELTED AND BROKEN AT THE MAIN TUBE CONNECTION JOINT. THE MAIN TUBE REINFORCEMENT WAS MISSING FROM THE MAIN TUBE. THE MAIN TUBE WAS FOUND BROKEN AND CRACKED AT THE DISTAL TIP. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING THE INSTRUMENT HAD BEEN USED 8 TIMES. NO OTHER DAMAGE WAS FOUND. ON (B)(4) 2012, INTUITIVE SURGICAL, INC. (ISI) SPOKE WITH THE INITIAL REPORTER OF THE COMPLAINT. THE REPORTER STATED THE INITIALLY REPORTED COMPLAINT WAS INCORRECT THAT IN FACT, THE INSTRUMENT WAS NOT BRAND-NEW BUT RATHER HAD BEEN USED PREVIOUSLY. HE ALSO STATED THAT THERE WERE NO REPORTS OF ANY PATIENT HARM OR FRAGMENTS FALLING INTO ANY PATIENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING A BRAND NEW INSTRUMENT THE ORANGE SLEEVE WAS CRACKED. THE INSTRUMENT WAS NOT USED IN A CASE OR STERILIZED. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343103 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M14130603 795

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES, ESU