BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3813269 · Received May 15, 2014

    Report

    Report Number
    2955842-2014-03004
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP CLOSE CABLE BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CABLE INSIDE THE MEGA NEEDLE DRIVER INSTRUMENT SNAPPED DURING A DA VINCI ABDOMINAL SACRAL COLPOPEXY PROCEDURE AND THE SUTURE FELL INTO PELVIC FLOOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ABDOMINAL SACRAL COLPOPEXY PROCEDURE, THE DOCTOR WAS SUTURING MESH INTO THE PELVIC FLOOR AND THE CABLE INSIDE THE MEGA NEEDLE DRIVER INSTRUMENT SNAPPED. THE SUTURE FELL INTO PELVIC FLOOR WHEN INSTRUMENT BROKE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORTED COMPLAINT. ON (B)(6) 2014, CUSTOMER REPLIED BACK INDICATING THAT THE SUTURE WAS RETRIEVED LAPAROSCOPICALLY. NO ADDITIONAL SURGICAL PROCEDURE AND NO POST-OPERATIVE TEST WERE REQUIRED TO RETRIEVE THE SUTURE. THE SURGEON BELIEVES THAT THE CABLE INSIDE THE INSTRUMENT WAS WEAK, CAUSING IT TO BREAK. THERE WAS NO ALLEGATION OF PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289407 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-10 M10140107 063

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR