BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 2111686 · Received June 2, 2011

    Report

    Report Number
    2955842-2011-00164
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 3, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    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 THE HOOK BROKEN OFF OF THE INSTRUMENT. THE HOOK HAD FRACTURED WITHIN THE YAW PULLEY, AT THE CROSS SECTION OF THE HOLE FEATURE. THE DETACHED HOOK WAS NOT RETURNED. ENGINEERING ALSO OBSERVED THAT ONE SIDE OF THE CERAMIC SLEEVE IS BROKEN OFF AND MISSING. THE SIZE OF THE MISSING PIECE IS APPROXIMATELY .155 X .075. IT WAS DETERMINED THAT THE DAMAGE TO THE HOOK AND SLEEVE MAY BE DUE TO OVERLOADING AT THE TIP OR OTHER MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED. PER THE INFORMATION PROVIDED BY THE INITIAL REPORTER, THE BROKEN INSTRUMENT PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SIGMOID COLECTOMY THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT BROKE AND A PIECE FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-05 M10100505 402

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM, ACCESSORIES & ESU