BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEM-O-LOK CLIP APPLIERINSTRUMENT

    MDR report key: 3070821 · Received April 22, 2013

    Report

    Report Number
    2955842-2013-01338
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 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 THE ONE OF THE GRIP CLOSE CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY AND THE FRAYED STRANDS WERE STICKING OUT AT THE WRIST. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WERE DERAILED CABLES, MAIN TUBE DAMAGE, AND A CRACKED HOUSING. THE SAME GRIP CABLE THAT WAS FRAYED WAS ALSO DERAILED FROM THE DISTAL IDLER PULLEY. ENGINEERING CONCLUDED THAT THE DERAILMENT MOST LIKELY CONTRIBUTED TO FRAYING. THE MAIN TUBE EXHIBITED WEARING WITH MATERIAL REMOVAL AND A ROUGH SURFACE FINISH ALL ALONG ITS LENGTH. THE INSTRUMENT'S HOUSING WAS DISCOLORED AND CRACKED ON THE TOP AND SIDE SURFACES. ENGINEERING CONCLUDED THAT THE DAMAGE TO THE HOUSING AND MAIN TUBE MAY BE DUE TO IMPROPER CLEANING. NO OTHER DAMAGE FOUND. 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 SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED BROKEN CABLES ON THE TIP OF THE HEM-O-LOK CLIP APPLIER INSTRUMENT .NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT REPORTEDLY 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
    173039 LARGE HEM-O-LOK CLIP APPLIERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420230-04 M10110316 099

    Patients

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