BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19846552 · Received July 27, 2024

    Report

    Report Number
    2955842-2024-17531
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    May 23, 2024
    Report Date
    July 10, 2024
    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
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP THAT IS COMPLETELY DETACHED FROM THE BASE OF THE GRIP. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN JAWS WHEN LOADING INTO TRITAN. THE CUSTOMER COMPLETED THE PROCEDURE USING THE SAME SYSTEM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE WAS OBSERVED PRIOR TO REPROCESSING. THE INSTRUMENT IS ALWAYS INSPECTED IN DECONTAMINATION, PREP/PACK AND AGAIN IN THE OPERATING ROOM (OR). THE INSTRUMENT WAS DAMAGED IN THE SONIC WASHER AND THE FRAGMENTS WERE RETAINED BY THE CUSTOMER. NO FRAGMENT FELL INTO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776469 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10240215 0652

    Patients

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