BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 16928158 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13577
    Event Type
    Injury
    Date Received
    May 13, 2023
    Date of Event
    January 12, 2021
    Report Date
    January 13, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111642
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT "ONE MOUTH OF THE FENESTRATED BIPOLAR FORCEPS HAS BENT AND IS BROKEN OFF". FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF "ONE MOUTH OF THE FENESTRATED BIPOLAR FORCEPS HAS BENT AND IS BROKEN OFF" TO BE RELATED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY .210" X .545" WAS FOUND TO BE BROKEN OFF THE YAW PULLEY. THE BROKEN PIECE WAS RETURNED. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE A SEVERELY BENT GRIP. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS WAS BENT AND BROKE OFF. THE FRAGMENT WAS REMOVED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS IN USE APPROXIMATELY 2 HOURS PRIOR TO THE ISSUE. IT CANNOT BE RULED OUT THAT THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS. THE INSTRUMENT'S JAWS BROKE OFF DURING A PREPARATION IN A "NARROW SPACE." THE FRAGMENT WAS RETRIEVED IMMEDIATELY. THE SURGERY WAS COMPLETED USING A BACKUP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651591 ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420205-16 N10201005 425 00886874111642

    Patients

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