BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17741332 · Received September 13, 2023

    Report

    Report Number
    2955842-2023-18432
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    July 10, 2023
    Report Date
    August 16, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED USERFACILITY REPORT 0300240000-2023-8010 STATING: WHILE SURGEON WAS USING MEGA SUTURECUT NEEDLE DRIVER, THE SPRING BROKE MID-USE. ITEM WAS TAKEN OUT, INTACT AND SEQUESTERED FOR THE REMAINDER OF THE CASE. ORIGINAL INTENDED PROCEDURE: ROBOTIC LOW ANTERIOR RESECTION WITH PRIMARY ANASTOMOSIS ADDITIONAL PROCEDURE: ROBOTIC TEMPORARY DIVERTING LOOP ILEOSTOMY ADDITIONAL PROCEDURE: FLEXIBLE SIGMOIDOSCOPY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER DID NOT HAVE ANY OTHER INFORMATION. THE CUSTOMER SUBMITTED TO THE FDA ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789532 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K15230217 0353

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES