BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP COVER ACCESSORY

    MDR report key: 3644597 · Received February 25, 2014

    Report

    Report Number
    2955842-2014-01099
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 31, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. THE INSTRUMENT ACCESSORY IS DESIGNED AS A SINGLE USE ACCESSORY AND WAS FOUND TO BE UNDAMAGED. WARNING: FAILURE TO INSTALL THE TIP COVER ACCESSORY PROPERLY MAY RESULT IN: - IMPROPER SCISSOR OPENING - TIP COVER ACCESSORY FALLING OFF - ELECTRICAL ARCS AND ALTERNATE SITE BURNS GENERAL PRECAUTIONS AND WARNINGS - THE ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT MUST ALWAYS BE USED IN CONJUNCTION WITH THE TIP COVER ACCESSORY. - INSPECT THE TIP COVER ACCESSORY PERIODICALLY DURING USE. IF ANY DAMAGE OR TEARS ARE OBSERVED, REPLACE THE TIP COVER ACCESSORY WITH A NEW ONE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MONOPOLAR CURVED SCISSORS INSTRUMENT TIP COVER ACCESSORY FELL INTO THE PATIENT. PER THE INFORMATION PROVIDED, THE TIP COVER WAS RETRIEVED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON FEBRUARY 4, 2014, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER AT THE HOSPITAL AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. SHE INDICATED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AS PER THEIR NORMAL PROCESS. SHE STATED THAT THE CAUSE OF THE INSTRUMENT ACCESSORY FALLING INTO THE PATIENT IS UNKNOWN; HOWEVER, THE EVENT OCCURRED WHEN THE SURGEON WAS RETRIEVING THE SCISSORS. SHE STATED THAT THE FALLEN TIP COVER ACCESSORY WAS REMOVED LAPAROSCOPICALLY AND DENIED ANY X-RAYS WERE PERFORMED AS A RESULT OF THE REPORTED EVENT. SHE ALSO DENIED THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS BECAUSE OF THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MONOPOLAR CURVED SCISSORS INSTRUMENT TIP COVER ACCESSORY FELL INTO THE PATIENT. PER THE INFORMATION PROVIDED, THE TIP COVER WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT TIP COVER ACCESSORY FELL INTO THE PATIENT WHILE REMOVING THE INSTRUMENT. THE TIP COVER WAS RETRIEVED AND A NEW INSTRUMENT AND TIP COVER ACCESSORY WERE USED. 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
    115980 TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12 M10131003

    Patients

    Seq Age Sex Outcome Treatment
    1