BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23090316 · Received September 18, 2025

    Report

    Report Number
    2955842-2025-38602
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 27, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO 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 5MM X 1MM AND WAS ROUGHLY 0.5MM DEEP. THERE WAS MATERIAL MISSING. THE COMPLAINT REGARDING CRACKED INSTRUMENT SHEATH WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR AN ACCIDENTAL DROP OF THE INSTRUMENT. IMAGE REVIEW: A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THIS DOESN¿T LOOK LIKE A CRACK, BUT RATHER A SCRATCH IN THE LASER MARKED SECTION OF THE TUBE EXTENSION, RESULTING IN THE ORANGE PLASTIC UNDERNEATH THE LASER MARKING BEING EXPOSED. SCRATCHES TO THE TUBE EXTENSION ARE NOT LIKELY TO RESULT IN ARCING. 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. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A CRACKED SHEATH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT IS THE BROWN PART ABOVE THE ORANGE PART THAT IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802809 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K10250130 0082 00886874112298

    Patients

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