BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3092341 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01528
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 2, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE LOCATED AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.04 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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 MYOMECTOMY PROCEDURE, CUSTOMER REPORTED THAT WHILE THEY WERE SUTURING THE PATIENT'S UTERUS, THE SURGEON NOTICED THAT THE STRINGS OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WERE DETACHED FROM THE TIP. THE PROCEDURE WENT WELL AND WITH NO INCIDENT TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195126 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10120615 141

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR DA VINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIE