BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3203635 · Received July 3, 2013

    Report

    Report Number
    2955842-2013-02408
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. FOR CLARIFICATION, THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE A CONTAMINATED DALLAS CHIP. AFTER REMOVING THE HOUSING, A DARK LAYER OF RESIDUE WAS FOUND ON THE DALLAS CHIP. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY CLEANING RELATED. ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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 PRIOR TO STARTING A DA VINCI S PROSTATECTOMY PROCEDURE A TORN STRING WAS DETECTED. 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
    305210 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10120522 282

    Patients

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