BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19436127 · Received May 31, 2024

    Report

    Report Number
    2955842-2024-15140
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 2, 2024
    Report Date
    May 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    REFER TO SECTION D. SUSPECT MEDICAL DEVICE FOR UPDATED PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE HAS RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT EXHIBITS 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 1.00 MM X 2.0 MM. THERE WAS NOT ANY MATERIAL MISSING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE DEFECT WAS IN THE GREY AREA OF PART NUMBER 2 ON THE SHAFT, JUST BEHIND THE ORANGE AREA, NOT THE TIP COVER. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS INSPECTED BEFORE USE AND THE MCS TIP COVER HAD NO DEFECT, BUT THE SCISSORS HAD A HOLE ON THE SURFACE SHOWING THE ORANGE PART ON THE SHAFT. THE MCS DID NOT COLLIDE WITH OTHER INSTRUMENTS DURING SURGERY. THE SURGEON DID NOT NOTICE ANY ARCING AND THERE WAS NO THERMAL DAMAGE TO THE MCS OR THE MCS TIP COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SHEATH OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOTED TO HAVE A HOLE. NO FRAGMENT FELL INTO PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    309203 NONE MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K14230928 0511

    Patients

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