BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20971772 · Received December 18, 2024

    Report

    Report Number
    2955842-2024-23418
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. HOWEVER, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    A GENERAL REPORT WAS RECEIVED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURES, THE CUSTOMER HAS EXPERIENCED BROKEN FENESTRATED BIPOLAR FORCEPS INSTRUMENTS AT SEVERAL ASSOCIATED HOSPITALS. SPECIFIC EVENT AND DEVICE INFORMATION WAS NOT PROVIDED. IT WAS STATED THAT EACH PATIENT HAD INTRAOPERATIVE X-RAY IMAGING PERFORMED IN CASE A RETAINED PART OF A BROKEN WIRE DROPPED OFF IN THE PATIENT¿S CAVITY, WHICH IS BECOMING A PATIENT SAFETY CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116009 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205 N/A

    Patients

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