BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3092907 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01543
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER INITIALLY REPORTED A BROKEN WIRE, HOWEVER, FOR CLARIFICATION THE DAMAGED INSTRUMENT COMPONENT WAS A FRAYED PITCH CABLE. THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. NO OTHER CABLE DAMAGE WAS FOUND. ELECTRICAL CONTINUITY PASSED. ADDITIONAL FINDINGS NOT REPORTED WAS A PITCH CABLE WAS LOOSE AT DISTAL CLEVIS HUB. BOTH CABLE CRIMPS REMAINED IN THE CLEVIS. UPON HOUSING REMOVAL A PITCH CABLE WAS FOUND LOOSE AT THE CLAMPING PULLEY, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. THERE WERE ALSO SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. THE CLAMPING PULLEYS ALSO EXHIBITED CORROSION AROUND THE PULLEYS. ENGINEERING CONCLUDED THE FAILURE MAY BE CLEANING RELATED. 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 DURING REPROCESSING FENESTRATED BIPOLAR FORCEPS INSTRUMENT A CABLE WAS BROKEN AND THE INSTRUMENT WAS NOT WORKING PROPERLY. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195317 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10121210 358

    Patients

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