BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING RETRACTOR INSTRUMENT

    MDR report key: 2905380 · Received January 9, 2013

    Report

    Report Number
    2955842-2013-00107
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP, ONE IS MISSING IN CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO STARTING A DA VINCI SI MYOMECTOMY PROCEDURE THAT THE GRASPING RETRACTOR HAD A BROKEN CABLE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11136 GRASPING RETRACTOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420278-02 S10081121 017

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES