BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL GRASPING RETRACTOR INSTRUMENT

    MDR report key: 2944606 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00392
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE AT THE DISTAL CLEVIS HUB IS BROKEN AND THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT EXCESSIVE DAMAGE. THE BROKEN CABLE SEGMENT WAS ALSO RETURNED. ON (B)(4) 2013 ISI CONTACTED THE INITIAL REPORTER OF THIS INCIDENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON REPORTED THAT HE WAS NOT GRASPING TISSUE WITH THE SMALL GRASPER RETRACTOR INSTRUMENT AS THE INSTRUMENT WAS NOT RESPONDING. THE INITIAL REPORTER INDICATED THE SURGEON USED ANOTHER INSTRUMENT TO AID IN THE REMOVAL OF THE SMALL GRASPER RETRACTOR INSTRUMENT. THE INITIAL REPORTER INDICATED THAT TO THE BEST OF THEIR KNOWLEDGE, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROCTOCOLECTOMY PROCEDURE, THE WIRES ON THE SMALL GRASPING RETRACTOR INSTRUMENT BROKE AND A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED AND 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
    47528 SMALL GRASPING RETRACTOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420318-02 M10120927 935

    Patients

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