BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16686948 · Received April 5, 2023

    Report

    Report Number
    2955842-2023-11784
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    June 14, 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

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MCS INSTRUMENT DIDN'T CUT AND GOT STUCK ON TO THE TISSUE, 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 BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT TISSUE WAS STUCK IN THE INSTRUMENT'S JAWS WHEN THE INSTRUMENT FAILED TO CUT TISSUE. IT IS UNKNOWN IF THE CUSTOMER WAS ABLE TO RELEASE THE TISSUE WITH THE USE OF THE IRK,BY SURGEON COMMAND OR OTHER MEANS. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE INSTRUMENT FAILS TO RELEASE FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE EVENT 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS ABLE TO REPRODUCE AND CONFIRM THE CUSTOMER REPORTED ISSUE OF ¿DIDN¿T CUT AND STUCK ON TISSUE¿. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF MECHANICAL INDENTATIONS/BURRS TO THE BLADES TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE MCS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BLADE DAMAGE. ONE OF THE BLADE EDGES WAS INDENTED, THIS CAN PREVENT THE BLADES FROM CLOSING. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND A CUT TEST WAS PERFORMED. THE SCISSORS DID NOT CUT CLEANLY THROUGH 0.006" OF THE LATEX. THE LATEX GOT SNAGGED AT THE SCISSOR TIPS. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) DIDN'T CUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IT WAS FURTHER REPORTED THAT ASIDE FROM THE CUTTING ISSUE, THE INSTRUMENT GOT STUCK ON TO THE TISSUE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CTA CONFIRMED THAT THERE WAS NO UNEXPECTED OR UNPLANNED REMOVAL OF TISSUE DUE TO THE "STICKING SCISSORS" ISSUE. THE CUSTOMER WAS ABLE TO GET A SATISFACTORY AND ACCEPTABLE SURGICAL RESULT. THIS EVENT DID NOT CAUSE ANY INTRAOPERATIVE OR POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756000 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K14220214 0355 00886874112298

    Patients

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