BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20900911 · Received December 11, 2024

    Report

    Report Number
    2955842-2024-22983
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 15, 2024
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER SITE IS UNKNOWN. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE IN USE DURING SCHEDULED PROCEDURE - EXPOSED WIRING. DURING THE ROBOT ASSISTED PROCEDURE, WHEN THE SURGEON AS USING THE FENESTRATED BIPOLAR FORCEPS, THE INSTRUMENT ARM BROKE. AT THE INSTRUMENT ARM WRIST, THERE WAS EXPOSED WIRING, AND THE ARM WAS NONFUNCTIONAL. THE INSTRUMENT HAD 9/14 USES LEFT. THE PROCEDURE WAS UNKNOWN HOW IT WAS COMPLETED. ON 11/15/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MAUDE REPORT 19948859 STATING: FENESTRATED BIPOLAR FORCEPS BROKE IN USE DURING SCHEDULED PROCEDURE - EXPOSED WIRING. DURING THE ROBOT ASSISTED PROCEDURE, WHEN THE SURGEON WAS USING THE FENESTRATED BIPOLAR FORCEPS, THE INSTRUMENT ARM BROKE. AT THE INSTRUMENT ARM WRIST, THERE WAS EXPOSED WIRING, AND THE ARM IS NONFUNCTIONAL. THE INSTRUMENT HAD 9/14 USES LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597585 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 N/A 00886874119808

    Patients

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