BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3010833 · Received March 19, 2013

    Report

    Report Number
    2955842-2013-00892
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    November 28, 2012
    Report Date
    February 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT BOTH PITCH CABLES WERE FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. BOTH CABLE SEGMENTS THAT CONTAIN THE CRIMP WERE STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS A MISSING PIECE. THE YAW PULLEY BELOW THE BASE WAS MISSING A PIECE ON ONE OF THE GRIPS. THE YAW PULLEY ALSO EXHIBITED LOCALIZED CHARRING. INTERNAL LABORATORY TESTING HAS DETERMINED THAT THE ARC TRACK FAILURE MODE IS MOST LIKELY TO OCCUR WHEN A BIPOLAR INSTRUMENT IS ENERGIZED WITH NO TISSUE BETWEEN THE GRIPS. INTERNAL ARCING IN BIPOLAR INSTRUMENTS RESULTS IN A POTENTIAL LOSS OF PRODUCT FUNCTION, BUT NO TRANSFER OF ENERGY TO THE PATIENT. INTUITIVE HAS CONCLUDED THAT THE LIKELIHOOD OF INJURY DUE TO THIS FAILURE IS REMOTE. USER ARE INSTRUCTED TO RETAIN BACK-UP INSTRUMENTS IN CASE THAT AN INSTRUMENT FAILS TO PERFORM, AND ARE ALSO INSTRUCTED IN PROPER TECHNIQUE TO MINIMIZE THE LIKELIHOOD OF INTERNAL ARCING. 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

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE STRINGS OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT SNAPPED OFF ON BOTH SIDES. THE PROCEDURE WENT WELL AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114739 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10120522 330

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES