BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA

    MDR report key: 3013279 · Received March 20, 2013

    Report

    Report Number
    2955842-2013-00921
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2012, THE INTUITIVE SURGICAL TECHNICAL SERVICE ENGINEER (TSE) HAD THE CUSTOMER RESEAT THE STERILE ADAPTER BUT THE REPORTED ISSUE WAS NOT RESOLVED. IN ADDITION, THE CUSTOMER PERFORMED AN EMERGENCY POWER OFF (EPO) AND A POWER CYCLE SYSTEM BUT THE ISSUE WAS STILL NOT RESOLVED. THE CUSTOMER CLAIMED THAT THE INSTRUMENTS WERE REALLY DIFFICULT TO INSERT AND REMOVE. THE INSTRUMENT CANNULA WAS INSPECTED AND FOUND TO BE CRACKED AND BENT OUT OF SHAPE. THE CUSTOMER REPLACED THE CANNULA AND WAS ABLE TO COMPLETE THE SURGICAL PROCEDURE. ON (B)(6) 2012, ISI CONTACTED THE TSE AND OBTAINED ADDITIONAL INFORMATION. ACCORDING TO THE TSE, THE CANNULA WAS FOUND TO BE CRACKED UPON REMOVAL OF THE CANNULA. ACCORDING TO THE TSE, THE CUSTOMER INSTALLED A NEW CANNULA AND THE ISSUE WAS RESOLVED. THE TSE DID NOT KNOW WHEN THE CANNULA WAS DAMAGED. HE ALSO WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE CANNULA. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) PROCEDURE, THE SURGEON WAS HAVING ISSUES WITH ARM 1 CONTROL. THE SURGEON REPORTEDLY EXPERIENCED RESISTANCE ROTATING AND INSERTING AN INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. 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
    116330 CANNULA ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES