BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16925267 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13185
    Event Type
    Malfunction
    Date Received
    May 13, 2023
    Date of Event
    March 2, 2020
    Report Date
    March 9, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111352
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PRECISE BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT TO HAVE A BROKEN CONDUCTOR WIRE AT THE YAW PULLEY. THE CONDUCTOR WIRE WAS BROKEN AT THE GRIP-CRIMP LOCATION. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THERE WERE NO SIGNS OF THERMAL DAMAGE OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BIPOLAR YAW PULLEY. A BROKEN PIECE APPROXIMATELY 0.068 X 0.120 IN SIZE WAS MISSING AS A RESULT OF BREAKAGE. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE DISTAL END OF THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A 0.024 OFFSET AT THE TIPS. THE GRIP TIPS WAS ALSO FOUND TO HAVE VARIOUS SCRATCH MARKS. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE 0.070 - 0.196 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PRECISE BIPOLAR FORCEPS INSTRUMENT JAWS WOULD NOT OPEN. 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 JAWS OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT WOULD NOT OPEN. THE ISSUE WAS IDENTIFIED DURING SURGERY AND CAUSED A PROCEDURE DELAY OF LESS THAN 15 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT WITH NO ADVERSE EFFECT OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031659 ENDOWRIST PRECISE BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420110-10 N10180705 084 00886874111352

    Patients

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