BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT SHEARS (TM) (MONOPOLARCURVED SCISSORS)

    MDR report key: 2920135 · Received January 17, 2013

    Report

    Report Number
    2955842-2013-00220
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 18, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT OF TIPS BEING LOOSE CANNOT BE CONFIRMED. THE SCISSORS ARE NOT DAMAGED AND DRIVE CABLES ARE NOT LOOSE AT THE WRIST UPON VISUAL INSPECTION. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE ARE A CRACKED TUBE EXTENSION AND TUBE DAMAGE. THE TUBE EXTENSION IS CRACKED AT THE PROXIMAL CLEVIS INTERFACE. THE TUBE EXTENSION FRACTURED NEXT TO ONE OF THE KEYS THAT MATES WITH THE PROX CLEVIS. THE EVIDENCE WAS NOT CONCLUSIVE, BUT THE TUBE EXTENSION LIKELY CRACKED DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING/MISUSE. THE DISTAL END OF THE MAIN TUBE HAS A 1 LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. THERE WAS 1 USE LEFT. NO OTHER DAMAGE WAS FOUND. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. BASED ON THIS, NO ADDITIONAL FOLLOW UP IS REQUIRED. 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 INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVE. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE TIPS ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT WERE LOOSE. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25493 HOT SHEARS (TM) (MONOPOLARCURVED SCISSORS) ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11120911 829

    Patients

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