BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM SMALL GRASPING RETRACTORINSTRUMENT

    MDR report key: 6183626 · Received December 16, 2016

    Report

    Report Number
    2955842-2016-00903
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 10, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS FOUND A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. BROKEN STRANDS STUCK OUT AT THE WRIST OF THE INSTRUMENT. THE CRIMP WAS NOT MISSING. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, IT WAS OBSERVED THAT A CABLE WAS COMING LOOSE FROM THE PULLEY SYSTEM ON THE HINGE OF THE SMALL GRASPING RETRACTOR INSTRUMENT AT THE TIP OF THE ARM. THE CABLE WAS SEEN BROKEN AND LOOSE AT THE HINGE BEFORE THE TIP. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834066 8 MM SMALL GRASPING RETRACTORINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470318-07 S10141219 0018

    Patients

    Seq Age Sex Outcome Treatment
    1