BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3790947 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02781
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    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 MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI SURGICAL PROCEDURE, THE CABLE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE, REQUIRING THE PATIENT TO UNDERGO AN X-RAY TO DETERMINE IF THE PATIENT HAD RETAINED ANY PIECE(S) FROM THE INSTRUMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, INTUITIVE SURGICAL RECEIVED MFR REPORT (B)(4) WITH THE FOLLOWING COMPLAINT DESCRIPTION: DURING CASE, DA VINCI 8 MM MEGA SUTURECUT NEEDLE DRIVER BROKEN WITH CABLE PROTRUDING ON THE TIP AND BOTH TIPS STILL ATTACHED. DEVICE PRE-CHECKED PRIOR TO USE, NO INDICATION OF ANY PROBLEM. WORKING FOR FEW HOURS DURING CASE WHEN SURGEON NOTIFIED SURGICAL TECHNICAL TO REMOVE DEVICE FROM SITE. DISCOVERED BY ATTENDING SURGEON WHEN DEVICE FAILED TO FUNCTION. X-RAYS ORDERED AND TAKE. NO VISIBLE PART LEFT PER X-RAY. BROKEN INSTRUMENT COMPARED TO NON-BROKEN ONE. ALL PARTS APPEARED TO BE PRESENT. THIS WAS USE 8 OF 10 FOR THIS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267485 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10130906 713

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention