BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2871147 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01295
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    GEI
    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. CUSTOMER INITIALLY REPORTED WIRES AT TIP FELL OFF. HOWEVER, FOR CLARIFICATION, THE PRODUCT PROBLEM WAS A BROKEN GRIP CABLE. BASED ON THIS, THE COMPLAINT WAS CONFIRMED. ONE GRIP CABLE IS BROKEN AT THE DISTAL IDLERS. IDLER PULLEY SPINS FREELY. IDLER AXLE SHOWED RIM DAMAGE AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED THE WIRE LOCATED AT THE TIP OF THE TENACULUM FORCEPS INSTRUMENT FELL INTO THE PATIENT. THE INSTRUMENT FRAGMENT WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, INJURY OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL,INC. 420207-06 M10110915 244

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES