BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19495618 · Received June 9, 2024

    Report

    Report Number
    2955842-2024-15349
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    March 29, 2024
    Report Date
    May 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL (IS) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT HAS BEEN SHIPPED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ANALYZED AND FOUND TO EXHIBIT SCRATCH MARKS/ABRASIONS ON THE BROWN LASER MARKED SECTION OF THE TUBE EXTENSION. AS A RESULT, THE ORANGE PLASTIC BENEATH THE LASER MARKING WAS EXPOSED. TUBE EXTENSION SCRATCH MARKS MEASURED ROUGHLY 2.6MM X 1.0MM. THERE WAS NO MATERIAL MISSING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE DISTAL PART OF THE MONOPOLAR CURVED SCISSORS (MCS) INSULATING SHEATH WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT CABLE INSULATION WAS DAMAGED. IT WAS NOT POSSIBLE TO CONFIRM THE TYPE OF DAMAGE OBSERVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125828 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K13231130 0090 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES.