BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2970801 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00573
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .055 OFFSET AT THE TIPS, INDICATING THAT OVERLOADING AT THE TIP OCCURRED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP REMAINED INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE TIPS ON THE PK DISSECTING FORCEPS INSTRUMENT WERE OBSERVED TO BE MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74975 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120523 553

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYS. INSTRUMENTS AND ACCESSORIES