BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3891906 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03860
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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 .111 BETWEEN THE GRIPS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE INSTRUMENT BLADE WAS SLIGHTLY BENT AT THE CABLE AND BLADE INTERFACE; HOWEVER, THE KNIFE WAS STILL ABLE TO CUT. IT WAS CONCLUDED THAT THE BENT BLADE DAMAGE WAS LIKE DUE TO MISHANDLING/MISUSE. THE SNAKE WRIST WAS DISLODGED WHERE THE MALE AND FEMALE DISKS MEET NEAR THE DISTAL CLEVIS HUB. IT WAS CONCLUDED THAT THE DISLODGED SNAKE WRIST DAMAGE WAS LIKE DUE TO MISHANDLING/MISUSE. THE 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 DAMAGE TO THE INSTRUMENT'S SNAKE WRIST 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 HYSTERECTOMY PROCEDURE, AN ERROR MESSAGE WAS RECEIVED INDICATING THAT THE BLADE MAY BE EXPOSED ON THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT. 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
    368367 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 M11140407 362

    Patients

    Seq Age Sex Outcome Treatment
    1