BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED NEEDLE DRIVER INSTRUMENT

    MDR report key: 4252171 · Received November 14, 2014

    Report

    Report Number
    2955842-2014-05676
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    August 11, 2014
    Report Date
    October 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K122532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. 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 FAILURE ANALYSIS EVALUATION). THE SITE'S ASSOCIATE RISK MANAGER PROVIDED A PHOTOGRAPH OF THE DISTAL END OF THE SUBJECT INSTRUMENT INVOLVED WITH THIS COMPLAINT. THE PHOTOGRAPH OF THE INSTRUMENT WAS EVALUATED BY ISI FAILURE ANALYSIS. BASED ON THE PHOTOGRAPH PROVIDED, IT APPEARS ONE DISTAL CLEVIS EAR IS BROKEN, AS A RESULT, LEAVING THE GRIPS HANGING LOOSE AND DECREASING THE INSTRUMENT'S PERFORMANCE. THE CLEVIS PIN APPEARS TO STILL BE ATTACHED TO THE BROKEN PIECE AND GRIPS. THE DISTAL CLEVIS LIKELY BROKE BECAUSE AN EXCEEDING LOAD WAS APPLIED TO THE DISTAL END THAT WAS GREATER THAN THE MATERIAL STRENGTH. SINCE THE INSTRUMENT WAS NOT RETURNED, NO FURTHER FAILURE ANALYSIS CAN BE PERFORMED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI SURGICAL PROCEDURE, FRAGMENTS FROM THE CURVED NEEDLE DRIVER INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENTS WERE RETRIEVED AND THERE WAS NO INDICATION THAT A SERIOUS PATIENT INJURY OCCURRED. THE CUSTOMER REPORTED COMPLAINT OF FRAGMENTS BREAKING OFF OF THE INSTRUMENT 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

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: THE PATIENT WAS UNDERGOING A SINGLE SITE ROBOTIC TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (TAH-BSO) AND CYSTOSCOPY. THE SURGEON WAS USING A SINGLE SITE CURVED NEEDLE DRIVER TO COMPLETE THE SUTURING AT THE END OF THE CASE, WHEN THE HEAD OF THE NEEDLE DRIVER TO COMPLETE THE SUTURING AT THE END OF THE CASE, WHEN THE HEAD OF THE NEEDLE DRIVER BROKE OFF INTO THE PATENT. THE SURGEON HAD TO LOCATE AND REMOVE SEVERAL LOOSE PIECES FROM THE PATIENT, PROLONGING TIME UNDER ANESTHESIA. THE SIDE OF THE DRIVER TIP, WHICH IS MADE OF HARD PLASTIC, APPEARS TO HAVE BROKEN OFF. IT IS ALSO UNCLEAR WHETHER A SMALL PIECE OF GRAY MATERIAL THAT HOLDS THE DRIVER HINGE IN PLACE WAS MISSING ON THIS NEEDLE DRIVER. IT WAS NOT FOUND IN THE PATIENT OR IN THE MATERIAL RETURNED TO US FROM THE OPERATING ROOM. WE THINK IT MAY NOT HAVE BEEN PLACED ON THE HINGE DURING MANUFACTURING, THUS ALLOWING THE DRIVER TO FALL APART AND BREAK UNDER TENSION. WE HAVE PHOTOS FOR REVIEW OF THE DRIVER WE RECOVERED AND A NEW DRIVER WE PULLED APART. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ASSOCIATE RISK MANAGER WHO INITIALLY REPORTED THIS COMPLAINT. ACCORDING TO THE ASSOCIATE RISK MANAGER, THE TIP OF THE INSTRUMENT BROKE APART TOWARDS THE END OF THE SURGICAL PROCEDURE WHILE THE SURGEON WAS SUTURING. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND LASTED 3 HOURS AND 41 MINUTES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737134 CURVED NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428088-13 S1013121 365

    Patients

    Seq Age Sex Outcome Treatment
    1