BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 4377790 · Received January 2, 2015

    Report

    Report Number
    2955842-2015-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    December 5, 2014
    Report Date
    February 2, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Removal / Correction Number
    2955842-11-15-2013-014-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT AND FOUND THAT THE INSTRUMENT CARBIDE INSERT WAS COMPLETELY BROKEN OFF AND MISSING. THE GRIPS/TIPS EXHIBITED SCRATCH MARKS ON THE SURFACE AND ONE INDENTATION EDGE ON THE SIDE THAT THE CARBIDE BROKE OFF. THE CARBIDE INSERT THAT BROKE OFF WAS NOT RETURNED WITH THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO FOLLOWING CONCLUSIONS: THE INSTRUMENT WAS RETURNED AND EVALUATED. THIS IS A FOLLOW-UP MDR REPORT DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE CARBIDE INSERT FROM THE LARGE NEEDLE DRIVER INSTRUMENT FELL OFF INTO THE PATIENT AND WAS RETRIEVED. THERE WAS NO ALLEGATION OF ANY PATIENT INJURY OR HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE CARBIDE INSERT FROM THE LARGE NEEDLE DRIVER INSTRUMENT FELL OFF INTO THE PATIENT. THEY WERE ABLE TO RETRIEVE IT. CUSTOMER INSISTED ON RETURNING THE INSTRUMENT ONLY, NOT THE INSERT. THERE WAS NO PATIENT INJURY, HARM OR ADVERSE EVENT. ON 12/11/2014, INTUITIVE SURGICAL, INC. OBTAINED ADDITIONAL INFORMATION FROM CUSTOMER AND INDICATED THAT THE FRAGMENT (INSERT) WAS RETRIEVED LAPAROSCOPICALLY AND DISCARDED. IT WAS NOTICED IMMEDIATELY AND REMOVED. NO ADDITIONAL SURGICAL PROCEDURES AND NO POST-OPERATIVE TESTS WERE REQUIRED. THE ROBOTIC HYSTERECTOMY SACRAL COLPOPEXY WENT VERY WELL AFTER THE FRAGMENT WAS REMOVED AND PATIENT OUTCOME WAS WELL. THE PHYSICIAN HAS NO INSIGHT AS TO THE CAUSE OF THE INSERT FALLING. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10110322 154

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR