BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 3052884 · Received April 11, 2013

    Report

    Report Number
    2955842-2013-01196
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE RETURNED INSTRUMENT HAD A FRAYED PITCH CABLE AT THE DISTAL END: THE FRAYED STRANDS WERE APPROXIMATELY 0.0985 IN LENGTH. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. NO OTHER DAMAGED CABLES WERE FOUND. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS MAIN TUBE DAMAGE. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED A COUPLE SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND HAD A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    PRIOR TO STARTING A DA VINCI SI PROCEDURE, THE USER FACILITY REPORTEDLY IDENTIFIED A BROKEN WIRE ON THE TENACULUMS FORCEPS INSTRUMENT'S WRIST. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154563 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10120322 152

    Patients

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