BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16694861 · Received April 6, 2023

    Report

    Report Number
    2955842-2023-11805
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 22, 2022
    Report Date
    March 10, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT THE MCS INSTRUMENT DID NOT CUT WELL ENOUGH. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF MECHANICAL INDENTATIONS/BURRS TO THE BLADES TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. ONE OF THE BLADE EDGES WAS INDENTED, WHICH PREVENTED THE BLADES FROM CLOSING. BLADES OF AN INSTRUMENT THAT HAD BURRS OR INDENTATIONS WOULD NOT BE ABLE TO CUT MATERIAL AS EXPECTED, LEADING TO THE NEED TO ATTEMPT MULTIPLE CUTS TO COMPLETE A TRANSECTION.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STUCK, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT MCS INSTRUMENT GOT STUCK. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT AN MOVING INSTRUMENT MECHANISM WITHIN AN INSTRUMENT ENTRAPS TISSUE AND CAUSES DAMAGE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE DEVICE ENTRAPMENT ISSUE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WOULD NOT CUT WELL ENOUGH AND WAS STUCK. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY NOR DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO UNEXPECTED REMOVAL OF TISSUE DUE TO STICKING MCS INSTRUMENT. THE SURGICAL RESULT WAS SATISFACTORY AND ACCEPTABLE. NO INTRA OR POST OPERATIVE COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549046 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K12210816 0021 00886874112298

    Patients

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