BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24810146 · Received April 7, 2026

    Report

    Report Number
    2955842-2026-20732
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT RUBBER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: REPORTER SENT A PICTURE THAT HAD BEEN TAKEN BY THE STERILIZATION CENTER. PUT THE PICTURE IN THE BOX WITH THE INSTRUMENT. IT LOOKS LIKE THERE WAS DAMAGE TO THE CONDUCTOR WIRE. COULD NOT BE SEEN WITH THE NAKED EYE, BUT IN THE PICTURE WITH MAGNIFICATION IT COULD LOOK LIKE IT WAS WORN/CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451783 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K14240912 0054 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1