BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3043268 · Received April 9, 2013

    Report

    Report Number
    2955842-2013-01158
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K072627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS OR WITH OTHER CABLES. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE INSTRUMENT AND PASSED. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS PULLEY SCRATCHES AND MAIN TUBE DAMAGE. THE SURFACE OF THE DISTAL PULLEY HAD SCRATCHES. IN ADDITION, 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

    THE USER FACILITY REPORTEDLY IDENTIFIED A FRAYED CABLE FROM THE PK DISSECTING FORCEPS INSTRUMENT DURING CENTRAL PROCESSING. 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
    147193 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120312 429

    Patients

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