BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3092240 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01525
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 21, 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 PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. NO OTHER DAMAGE 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 ALMOST DONE SUTURING THE PATIENT'S UTERUS, THE SURGEON NOTICED THAT THE STRINGS ON THE MARYLAND BIPOLAR FORCEPS TIP SNAPPED MAKING THE ENDOWRIST INSTRUMENT DEFECTIVE. 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
    195010 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10121010 867

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR DA VINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIE