BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 4032372 · Received August 25, 2014

    Report

    Report Number
    2955842-2014-05162
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 29, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT BLADE WAS EXPOSED APPROXIMATELY .141 BETWEEN THE GRIPS. THE BLADE AND BLADE TRACK WERE FREE OF BIO DEBRIS. NEITHER THE BLADE CABLE NOR THE BLADE WAS BENT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS DRIVEN. THE INSTRUMENT MOVED INTUITIVELY AND SUCCESSFULLY PERFORMED A CUT TEST. THERE WAS NO DAMAGE TO THE CONDUCTOR WIRE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE TIP OF THE GRIPS HAD A SMALL SCRATCH MEASURING APPROXIMATELY .095 WHERE MATERIAL WAS LIFTED AND APPEARED TO BE MISSING MATERIAL. IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE MISSING MATERIAL ON THE GRIP TIP, FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PEDIATRIC CYST OF SPLEEN PROCEDURE, THE KNIFE BETWEEN THE JAWS OF THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513785 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M10140219 919

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR