BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 20996160 · Received December 21, 2024

    Report

    Report Number
    2955842-2024-23533
    Event Type
    Malfunction
    Date Received
    December 21, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. AS A RESULT, THE GRIP TIP WAS DISLODGED. A BROKEN PIECE APPROXIMATELY 3.35MM X 9.55MM IN SIZE WAS MISSING AND NOT RETURNED WITH THE INSTRUMENT. THE COMPLAINT REGARDING THE BROKEN DEVICE WAS CONFIRMED BY FAILURE ANALYSIS BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, TIP OF FENESTRATED BIPOLAR FORCEPS WAS FOUND TO BE BROKEN. 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 DAMAGE THAT OCCURRED DID NOT OCCUR WHILE ARM WAS IN USE IN THE PATIENT. NO FRAGMENTS WERE REPORTED TO HAVE FALLEN INTO PATIENT AS IT DID NOT HAPPEN IN SURGICAL SITE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327661 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 K10240229 0029

    Patients

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